Medcomp Logo

Summary of Safety and Clinical Performance

{{ device_trade_names_english_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_english_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_english_professional }}

Manufacturer Name and Address: {{ manufacturer_info_english_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_english_professional }}

Basic UDI-DI: {{ basic_udi_di_english_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_english_professional }}

Class of Device: {{ class_of_device_english_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_english_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_english_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_english_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_english_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_english_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_english_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_english_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_english_professional }}

Indication(s): {{ indications_english_professional }}

Target Population(s): {{ target_populations_english_professional }}

Contraindications and/or Limitations: {{ contraindications_english_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_english_professional }}

Description of Device: {{ device_description_english_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_english_professional }} {{ material1_percentage_english_professional }}
{{ material2_name_english_professional }} {{ material2_percentage_english_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_english_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_english_professional }}

Sterilization Information: {{ sterilization_info_english_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_english_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_english_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_english_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_english_professional }}

{% for risk in residual_risk_quantification_english_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_english_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_english_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_english_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_english_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_english_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_english_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_english_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_english_professional }}

{% for outcome in performance_outcomes_english_professional %} {% endfor %} {% for outcome in safety_outcomes_english_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_english_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_english_professional }}

{% for therapy in therapeutic_alternatives_english_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_english_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_english_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_english_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: English {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_english_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_english_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_english_patient }}

Manufacturer Name and Address: {{ manufacturer_info_english_patient }}

Basic UDI-DI: {{ basic_udi_di_english_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_english_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_english_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_english_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_english_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_english_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_english_patient }}

Indication(s): {{ indications_english_patient }}

Target Population(s): {{ target_populations_english_patient }}

Contraindications and/or Limitations: {{ contraindications_english_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_english_patient }}

Description of Device: {{ device_description_english_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_english_patient }} {{ material1_percentage_english_patient }}
{{ material2_name_english_patient }} {{ material2_percentage_english_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_english_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_english_patient }}

Sterilization Information: {{ sterilization_info_english_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_english_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_english_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_english_patient }}

{% for risk in remaining_risks_table_english_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_english_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_english_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_english_patient }}

Safety

{{ safety_summary_english_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_english_patient }}

{% for therapy in therapeutic_alternatives_english_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_english_patient }}

Acronyms

{% for acronym in acronyms_english_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_bulgarian_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_bulgarian_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_bulgarian_professional }}

Manufacturer Name and Address: {{ manufacturer_info_bulgarian_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_bulgarian_professional }}

Basic UDI-DI: {{ basic_udi_di_bulgarian_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_bulgarian_professional }}

Class of Device: {{ class_of_device_bulgarian_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_bulgarian_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_bulgarian_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_bulgarian_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_bulgarian_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_bulgarian_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_bulgarian_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_bulgarian_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_bulgarian_professional }}

Indication(s): {{ indications_bulgarian_professional }}

Target Population(s): {{ target_populations_bulgarian_professional }}

Contraindications and/or Limitations: {{ contraindications_bulgarian_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_bulgarian_professional }}

Description of Device: {{ device_description_bulgarian_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_bulgarian_professional }} {{ material1_percentage_bulgarian_professional }}
{{ material2_name_bulgarian_professional }} {{ material2_percentage_bulgarian_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_bulgarian_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_bulgarian_professional }}

Sterilization Information: {{ sterilization_info_bulgarian_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_bulgarian_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_bulgarian_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_bulgarian_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_bulgarian_professional }}

{% for risk in residual_risk_quantification_bulgarian_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_bulgarian_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_bulgarian_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_bulgarian_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_bulgarian_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_bulgarian_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_bulgarian_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_bulgarian_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_bulgarian_professional }}

{% for outcome in performance_outcomes_bulgarian_professional %} {% endfor %} {% for outcome in safety_outcomes_bulgarian_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_bulgarian_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_bulgarian_professional }}

{% for therapy in therapeutic_alternatives_bulgarian_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_bulgarian_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_bulgarian_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_bulgarian_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Bulgarian {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_bulgarian_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_bulgarian_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_bulgarian_patient }}

Manufacturer Name and Address: {{ manufacturer_info_bulgarian_patient }}

Basic UDI-DI: {{ basic_udi_di_bulgarian_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_bulgarian_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_bulgarian_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_bulgarian_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_bulgarian_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_bulgarian_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_bulgarian_patient }}

Indication(s): {{ indications_bulgarian_patient }}

Target Population(s): {{ target_populations_bulgarian_patient }}

Contraindications and/or Limitations: {{ contraindications_bulgarian_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_bulgarian_patient }}

Description of Device: {{ device_description_bulgarian_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_bulgarian_patient }} {{ material1_percentage_bulgarian_patient }}
{{ material2_name_bulgarian_patient }} {{ material2_percentage_bulgarian_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_bulgarian_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_bulgarian_patient }}

Sterilization Information: {{ sterilization_info_bulgarian_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_bulgarian_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_bulgarian_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_bulgarian_patient }}

{% for risk in remaining_risks_table_bulgarian_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_bulgarian_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_bulgarian_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_bulgarian_patient }}

Safety

{{ safety_summary_bulgarian_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_bulgarian_patient }}

{% for therapy in therapeutic_alternatives_bulgarian_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_bulgarian_patient }}

Acronyms

{% for acronym in acronyms_bulgarian_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_czech_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_czech_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_czech_professional }}

Manufacturer Name and Address: {{ manufacturer_info_czech_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_czech_professional }}

Basic UDI-DI: {{ basic_udi_di_czech_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_czech_professional }}

Class of Device: {{ class_of_device_czech_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_czech_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_czech_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_czech_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_czech_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_czech_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_czech_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_czech_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_czech_professional }}

Indication(s): {{ indications_czech_professional }}

Target Population(s): {{ target_populations_czech_professional }}

Contraindications and/or Limitations: {{ contraindications_czech_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_czech_professional }}

Description of Device: {{ device_description_czech_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_czech_professional }} {{ material1_percentage_czech_professional }}
{{ material2_name_czech_professional }} {{ material2_percentage_czech_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_czech_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_czech_professional }}

Sterilization Information: {{ sterilization_info_czech_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_czech_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_czech_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_czech_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_czech_professional }}

{% for risk in residual_risk_quantification_czech_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_czech_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_czech_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_czech_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_czech_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_czech_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_czech_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_czech_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_czech_professional }}

{% for outcome in performance_outcomes_czech_professional %} {% endfor %} {% for outcome in safety_outcomes_czech_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_czech_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_czech_professional }}

{% for therapy in therapeutic_alternatives_czech_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_czech_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_czech_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_czech_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Czech {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_czech_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_czech_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_czech_patient }}

Manufacturer Name and Address: {{ manufacturer_info_czech_patient }}

Basic UDI-DI: {{ basic_udi_di_czech_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_czech_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_czech_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_czech_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_czech_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_czech_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_czech_patient }}

Indication(s): {{ indications_czech_patient }}

Target Population(s): {{ target_populations_czech_patient }}

Contraindications and/or Limitations: {{ contraindications_czech_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_czech_patient }}

Description of Device: {{ device_description_czech_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_czech_patient }} {{ material1_percentage_czech_patient }}
{{ material2_name_czech_patient }} {{ material2_percentage_czech_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_czech_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_czech_patient }}

Sterilization Information: {{ sterilization_info_czech_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_czech_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_czech_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_czech_patient }}

{% for risk in remaining_risks_table_czech_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_czech_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_czech_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_czech_patient }}

Safety

{{ safety_summary_czech_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_czech_patient }}

{% for therapy in therapeutic_alternatives_czech_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_czech_patient }}

Acronyms

{% for acronym in acronyms_czech_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_danish_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_danish_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_danish_professional }}

Manufacturer Name and Address: {{ manufacturer_info_danish_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_danish_professional }}

Basic UDI-DI: {{ basic_udi_di_danish_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_danish_professional }}

Class of Device: {{ class_of_device_danish_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_danish_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_danish_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_danish_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_danish_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_danish_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_danish_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_danish_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_danish_professional }}

Indication(s): {{ indications_danish_professional }}

Target Population(s): {{ target_populations_danish_professional }}

Contraindications and/or Limitations: {{ contraindications_danish_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_danish_professional }}

Description of Device: {{ device_description_danish_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_danish_professional }} {{ material1_percentage_danish_professional }}
{{ material2_name_danish_professional }} {{ material2_percentage_danish_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_danish_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_danish_professional }}

Sterilization Information: {{ sterilization_info_danish_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_danish_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_danish_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_danish_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_danish_professional }}

{% for risk in residual_risk_quantification_danish_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_danish_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_danish_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_danish_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_danish_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_danish_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_danish_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_danish_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_danish_professional }}

{% for outcome in performance_outcomes_danish_professional %} {% endfor %} {% for outcome in safety_outcomes_danish_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_danish_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_danish_professional }}

{% for therapy in therapeutic_alternatives_danish_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_danish_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_danish_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_danish_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Danish {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_danish_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_danish_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_danish_patient }}

Manufacturer Name and Address: {{ manufacturer_info_danish_patient }}

Basic UDI-DI: {{ basic_udi_di_danish_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_danish_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_danish_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_danish_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_danish_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_danish_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_danish_patient }}

Indication(s): {{ indications_danish_patient }}

Target Population(s): {{ target_populations_danish_patient }}

Contraindications and/or Limitations: {{ contraindications_danish_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_danish_patient }}

Description of Device: {{ device_description_danish_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_danish_patient }} {{ material1_percentage_danish_patient }}
{{ material2_name_danish_patient }} {{ material2_percentage_danish_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_danish_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_danish_patient }}

Sterilization Information: {{ sterilization_info_danish_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_danish_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_danish_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_danish_patient }}

{% for risk in remaining_risks_table_danish_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_danish_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_danish_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_danish_patient }}

Safety

{{ safety_summary_danish_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_danish_patient }}

{% for therapy in therapeutic_alternatives_danish_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_danish_patient }}

Acronyms

{% for acronym in acronyms_danish_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_german_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_german_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_german_professional }}

Manufacturer Name and Address: {{ manufacturer_info_german_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_german_professional }}

Basic UDI-DI: {{ basic_udi_di_german_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_german_professional }}

Class of Device: {{ class_of_device_german_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_german_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_german_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_german_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_german_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_german_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_german_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_german_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_german_professional }}

Indication(s): {{ indications_german_professional }}

Target Population(s): {{ target_populations_german_professional }}

Contraindications and/or Limitations: {{ contraindications_german_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_german_professional }}

Description of Device: {{ device_description_german_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_german_professional }} {{ material1_percentage_german_professional }}
{{ material2_name_german_professional }} {{ material2_percentage_german_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_german_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_german_professional }}

Sterilization Information: {{ sterilization_info_german_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_german_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_german_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_german_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_german_professional }}

{% for risk in residual_risk_quantification_german_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_german_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_german_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_german_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_german_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_german_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_german_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_german_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_german_professional }}

{% for outcome in performance_outcomes_german_professional %} {% endfor %} {% for outcome in safety_outcomes_german_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_german_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_german_professional }}

{% for therapy in therapeutic_alternatives_german_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_german_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_german_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_german_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: German {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_german_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_german_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_german_patient }}

Manufacturer Name and Address: {{ manufacturer_info_german_patient }}

Basic UDI-DI: {{ basic_udi_di_german_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_german_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_german_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_german_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_german_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_german_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_german_patient }}

Indication(s): {{ indications_german_patient }}

Target Population(s): {{ target_populations_german_patient }}

Contraindications and/or Limitations: {{ contraindications_german_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_german_patient }}

Description of Device: {{ device_description_german_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_german_patient }} {{ material1_percentage_german_patient }}
{{ material2_name_german_patient }} {{ material2_percentage_german_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_german_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_german_patient }}

Sterilization Information: {{ sterilization_info_german_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_german_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_german_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_german_patient }}

{% for risk in remaining_risks_table_german_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_german_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_german_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_german_patient }}

Safety

{{ safety_summary_german_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_german_patient }}

{% for therapy in therapeutic_alternatives_german_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_german_patient }}

Acronyms

{% for acronym in acronyms_german_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_greek_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_greek_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_greek_professional }}

Manufacturer Name and Address: {{ manufacturer_info_greek_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_greek_professional }}

Basic UDI-DI: {{ basic_udi_di_greek_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_greek_professional }}

Class of Device: {{ class_of_device_greek_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_greek_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_greek_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_greek_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_greek_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_greek_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_greek_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_greek_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_greek_professional }}

Indication(s): {{ indications_greek_professional }}

Target Population(s): {{ target_populations_greek_professional }}

Contraindications and/or Limitations: {{ contraindications_greek_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_greek_professional }}

Description of Device: {{ device_description_greek_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_greek_professional }} {{ material1_percentage_greek_professional }}
{{ material2_name_greek_professional }} {{ material2_percentage_greek_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_greek_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_greek_professional }}

Sterilization Information: {{ sterilization_info_greek_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_greek_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_greek_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_greek_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_greek_professional }}

{% for risk in residual_risk_quantification_greek_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_greek_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_greek_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_greek_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_greek_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_greek_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_greek_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_greek_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_greek_professional }}

{% for outcome in performance_outcomes_greek_professional %} {% endfor %} {% for outcome in safety_outcomes_greek_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_greek_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_greek_professional }}

{% for therapy in therapeutic_alternatives_greek_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_greek_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_greek_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_greek_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Greek {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_greek_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_greek_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_greek_patient }}

Manufacturer Name and Address: {{ manufacturer_info_greek_patient }}

Basic UDI-DI: {{ basic_udi_di_greek_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_greek_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_greek_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_greek_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_greek_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_greek_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_greek_patient }}

Indication(s): {{ indications_greek_patient }}

Target Population(s): {{ target_populations_greek_patient }}

Contraindications and/or Limitations: {{ contraindications_greek_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_greek_patient }}

Description of Device: {{ device_description_greek_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_greek_patient }} {{ material1_percentage_greek_patient }}
{{ material2_name_greek_patient }} {{ material2_percentage_greek_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_greek_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_greek_patient }}

Sterilization Information: {{ sterilization_info_greek_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_greek_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_greek_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_greek_patient }}

{% for risk in remaining_risks_table_greek_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_greek_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_greek_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_greek_patient }}

Safety

{{ safety_summary_greek_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_greek_patient }}

{% for therapy in therapeutic_alternatives_greek_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_greek_patient }}

Acronyms

{% for acronym in acronyms_greek_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_spanish_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_spanish_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_spanish_professional }}

Manufacturer Name and Address: {{ manufacturer_info_spanish_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_spanish_professional }}

Basic UDI-DI: {{ basic_udi_di_spanish_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_spanish_professional }}

Class of Device: {{ class_of_device_spanish_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_spanish_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_spanish_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_spanish_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_spanish_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_spanish_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_spanish_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_spanish_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_spanish_professional }}

Indication(s): {{ indications_spanish_professional }}

Target Population(s): {{ target_populations_spanish_professional }}

Contraindications and/or Limitations: {{ contraindications_spanish_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_spanish_professional }}

Description of Device: {{ device_description_spanish_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_spanish_professional }} {{ material1_percentage_spanish_professional }}
{{ material2_name_spanish_professional }} {{ material2_percentage_spanish_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_spanish_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_spanish_professional }}

Sterilization Information: {{ sterilization_info_spanish_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_spanish_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_spanish_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_spanish_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_spanish_professional }}

{% for risk in residual_risk_quantification_spanish_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_spanish_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_spanish_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_spanish_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_spanish_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_spanish_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_spanish_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_spanish_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_spanish_professional }}

{% for outcome in performance_outcomes_spanish_professional %} {% endfor %} {% for outcome in safety_outcomes_spanish_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_spanish_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_spanish_professional }}

{% for therapy in therapeutic_alternatives_spanish_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_spanish_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_spanish_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_spanish_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Spanish {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_spanish_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_spanish_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_spanish_patient }}

Manufacturer Name and Address: {{ manufacturer_info_spanish_patient }}

Basic UDI-DI: {{ basic_udi_di_spanish_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_spanish_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_spanish_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_spanish_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_spanish_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_spanish_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_spanish_patient }}

Indication(s): {{ indications_spanish_patient }}

Target Population(s): {{ target_populations_spanish_patient }}

Contraindications and/or Limitations: {{ contraindications_spanish_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_spanish_patient }}

Description of Device: {{ device_description_spanish_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_spanish_patient }} {{ material1_percentage_spanish_patient }}
{{ material2_name_spanish_patient }} {{ material2_percentage_spanish_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_spanish_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_spanish_patient }}

Sterilization Information: {{ sterilization_info_spanish_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_spanish_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_spanish_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_spanish_patient }}

{% for risk in remaining_risks_table_spanish_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_spanish_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_spanish_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_spanish_patient }}

Safety

{{ safety_summary_spanish_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_spanish_patient }}

{% for therapy in therapeutic_alternatives_spanish_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_spanish_patient }}

Acronyms

{% for acronym in acronyms_spanish_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_estonian_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_estonian_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_estonian_professional }}

Manufacturer Name and Address: {{ manufacturer_info_estonian_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_estonian_professional }}

Basic UDI-DI: {{ basic_udi_di_estonian_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_estonian_professional }}

Class of Device: {{ class_of_device_estonian_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_estonian_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_estonian_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_estonian_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_estonian_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_estonian_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_estonian_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_estonian_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_estonian_professional }}

Indication(s): {{ indications_estonian_professional }}

Target Population(s): {{ target_populations_estonian_professional }}

Contraindications and/or Limitations: {{ contraindications_estonian_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_estonian_professional }}

Description of Device: {{ device_description_estonian_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_estonian_professional }} {{ material1_percentage_estonian_professional }}
{{ material2_name_estonian_professional }} {{ material2_percentage_estonian_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_estonian_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_estonian_professional }}

Sterilization Information: {{ sterilization_info_estonian_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_estonian_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_estonian_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_estonian_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_estonian_professional }}

{% for risk in residual_risk_quantification_estonian_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_estonian_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_estonian_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_estonian_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_estonian_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_estonian_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_estonian_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_estonian_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_estonian_professional }}

{% for outcome in performance_outcomes_estonian_professional %} {% endfor %} {% for outcome in safety_outcomes_estonian_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_estonian_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_estonian_professional }}

{% for therapy in therapeutic_alternatives_estonian_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_estonian_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_estonian_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_estonian_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Estonian {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_estonian_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_estonian_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_estonian_patient }}

Manufacturer Name and Address: {{ manufacturer_info_estonian_patient }}

Basic UDI-DI: {{ basic_udi_di_estonian_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_estonian_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_estonian_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_estonian_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_estonian_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_estonian_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_estonian_patient }}

Indication(s): {{ indications_estonian_patient }}

Target Population(s): {{ target_populations_estonian_patient }}

Contraindications and/or Limitations: {{ contraindications_estonian_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_estonian_patient }}

Description of Device: {{ device_description_estonian_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_estonian_patient }} {{ material1_percentage_estonian_patient }}
{{ material2_name_estonian_patient }} {{ material2_percentage_estonian_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_estonian_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_estonian_patient }}

Sterilization Information: {{ sterilization_info_estonian_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_estonian_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_estonian_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_estonian_patient }}

{% for risk in remaining_risks_table_estonian_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_estonian_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_estonian_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_estonian_patient }}

Safety

{{ safety_summary_estonian_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_estonian_patient }}

{% for therapy in therapeutic_alternatives_estonian_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_estonian_patient }}

Acronyms

{% for acronym in acronyms_estonian_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_french_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_french_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_french_professional }}

Manufacturer Name and Address: {{ manufacturer_info_french_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_french_professional }}

Basic UDI-DI: {{ basic_udi_di_french_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_french_professional }}

Class of Device: {{ class_of_device_french_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_french_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_french_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_french_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_french_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_french_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_french_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_french_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_french_professional }}

Indication(s): {{ indications_french_professional }}

Target Population(s): {{ target_populations_french_professional }}

Contraindications and/or Limitations: {{ contraindications_french_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_french_professional }}

Description of Device: {{ device_description_french_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_french_professional }} {{ material1_percentage_french_professional }}
{{ material2_name_french_professional }} {{ material2_percentage_french_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_french_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_french_professional }}

Sterilization Information: {{ sterilization_info_french_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_french_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_french_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_french_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_french_professional }}

{% for risk in residual_risk_quantification_french_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_french_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_french_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_french_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_french_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_french_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_french_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_french_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_french_professional }}

{% for outcome in performance_outcomes_french_professional %} {% endfor %} {% for outcome in safety_outcomes_french_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_french_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_french_professional }}

{% for therapy in therapeutic_alternatives_french_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_french_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_french_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_french_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: French {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_french_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_french_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_french_patient }}

Manufacturer Name and Address: {{ manufacturer_info_french_patient }}

Basic UDI-DI: {{ basic_udi_di_french_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_french_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_french_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_french_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_french_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_french_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_french_patient }}

Indication(s): {{ indications_french_patient }}

Target Population(s): {{ target_populations_french_patient }}

Contraindications and/or Limitations: {{ contraindications_french_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_french_patient }}

Description of Device: {{ device_description_french_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_french_patient }} {{ material1_percentage_french_patient }}
{{ material2_name_french_patient }} {{ material2_percentage_french_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_french_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_french_patient }}

Sterilization Information: {{ sterilization_info_french_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_french_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_french_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_french_patient }}

{% for risk in remaining_risks_table_french_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_french_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_french_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_french_patient }}

Safety

{{ safety_summary_french_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_french_patient }}

{% for therapy in therapeutic_alternatives_french_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_french_patient }}

Acronyms

{% for acronym in acronyms_french_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_croatian_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_croatian_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_croatian_professional }}

Manufacturer Name and Address: {{ manufacturer_info_croatian_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_croatian_professional }}

Basic UDI-DI: {{ basic_udi_di_croatian_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_croatian_professional }}

Class of Device: {{ class_of_device_croatian_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_croatian_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_croatian_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_croatian_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_croatian_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_croatian_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_croatian_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_croatian_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_croatian_professional }}

Indication(s): {{ indications_croatian_professional }}

Target Population(s): {{ target_populations_croatian_professional }}

Contraindications and/or Limitations: {{ contraindications_croatian_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_croatian_professional }}

Description of Device: {{ device_description_croatian_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_croatian_professional }} {{ material1_percentage_croatian_professional }}
{{ material2_name_croatian_professional }} {{ material2_percentage_croatian_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_croatian_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_croatian_professional }}

Sterilization Information: {{ sterilization_info_croatian_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_croatian_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_croatian_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_croatian_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_croatian_professional }}

{% for risk in residual_risk_quantification_croatian_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_croatian_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_croatian_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_croatian_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_croatian_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_croatian_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_croatian_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_croatian_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_croatian_professional }}

{% for outcome in performance_outcomes_croatian_professional %} {% endfor %} {% for outcome in safety_outcomes_croatian_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_croatian_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_croatian_professional }}

{% for therapy in therapeutic_alternatives_croatian_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_croatian_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_croatian_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_croatian_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Croatian {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_croatian_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_croatian_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_croatian_patient }}

Manufacturer Name and Address: {{ manufacturer_info_croatian_patient }}

Basic UDI-DI: {{ basic_udi_di_croatian_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_croatian_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_croatian_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_croatian_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_croatian_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_croatian_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_croatian_patient }}

Indication(s): {{ indications_croatian_patient }}

Target Population(s): {{ target_populations_croatian_patient }}

Contraindications and/or Limitations: {{ contraindications_croatian_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_croatian_patient }}

Description of Device: {{ device_description_croatian_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_croatian_patient }} {{ material1_percentage_croatian_patient }}
{{ material2_name_croatian_patient }} {{ material2_percentage_croatian_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_croatian_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_croatian_patient }}

Sterilization Information: {{ sterilization_info_croatian_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_croatian_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_croatian_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_croatian_patient }}

{% for risk in remaining_risks_table_croatian_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_croatian_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_croatian_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_croatian_patient }}

Safety

{{ safety_summary_croatian_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_croatian_patient }}

{% for therapy in therapeutic_alternatives_croatian_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_croatian_patient }}

Acronyms

{% for acronym in acronyms_croatian_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_hungarian_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_hungarian_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_hungarian_professional }}

Manufacturer Name and Address: {{ manufacturer_info_hungarian_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_hungarian_professional }}

Basic UDI-DI: {{ basic_udi_di_hungarian_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_hungarian_professional }}

Class of Device: {{ class_of_device_hungarian_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_hungarian_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_hungarian_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_hungarian_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_hungarian_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_hungarian_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_hungarian_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_hungarian_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_hungarian_professional }}

Indication(s): {{ indications_hungarian_professional }}

Target Population(s): {{ target_populations_hungarian_professional }}

Contraindications and/or Limitations: {{ contraindications_hungarian_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_hungarian_professional }}

Description of Device: {{ device_description_hungarian_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_hungarian_professional }} {{ material1_percentage_hungarian_professional }}
{{ material2_name_hungarian_professional }} {{ material2_percentage_hungarian_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_hungarian_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_hungarian_professional }}

Sterilization Information: {{ sterilization_info_hungarian_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_hungarian_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_hungarian_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_hungarian_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_hungarian_professional }}

{% for risk in residual_risk_quantification_hungarian_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_hungarian_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_hungarian_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_hungarian_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_hungarian_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_hungarian_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_hungarian_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_hungarian_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_hungarian_professional }}

{% for outcome in performance_outcomes_hungarian_professional %} {% endfor %} {% for outcome in safety_outcomes_hungarian_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_hungarian_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_hungarian_professional }}

{% for therapy in therapeutic_alternatives_hungarian_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_hungarian_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_hungarian_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_hungarian_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Hungarian {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_hungarian_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_hungarian_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_hungarian_patient }}

Manufacturer Name and Address: {{ manufacturer_info_hungarian_patient }}

Basic UDI-DI: {{ basic_udi_di_hungarian_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_hungarian_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_hungarian_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_hungarian_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_hungarian_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_hungarian_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_hungarian_patient }}

Indication(s): {{ indications_hungarian_patient }}

Target Population(s): {{ target_populations_hungarian_patient }}

Contraindications and/or Limitations: {{ contraindications_hungarian_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_hungarian_patient }}

Description of Device: {{ device_description_hungarian_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_hungarian_patient }} {{ material1_percentage_hungarian_patient }}
{{ material2_name_hungarian_patient }} {{ material2_percentage_hungarian_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_hungarian_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_hungarian_patient }}

Sterilization Information: {{ sterilization_info_hungarian_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_hungarian_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_hungarian_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_hungarian_patient }}

{% for risk in remaining_risks_table_hungarian_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_hungarian_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_hungarian_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_hungarian_patient }}

Safety

{{ safety_summary_hungarian_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_hungarian_patient }}

{% for therapy in therapeutic_alternatives_hungarian_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_hungarian_patient }}

Acronyms

{% for acronym in acronyms_hungarian_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_italian_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_italian_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_italian_professional }}

Manufacturer Name and Address: {{ manufacturer_info_italian_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_italian_professional }}

Basic UDI-DI: {{ basic_udi_di_italian_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_italian_professional }}

Class of Device: {{ class_of_device_italian_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_italian_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_italian_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_italian_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_italian_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_italian_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_italian_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_italian_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_italian_professional }}

Indication(s): {{ indications_italian_professional }}

Target Population(s): {{ target_populations_italian_professional }}

Contraindications and/or Limitations: {{ contraindications_italian_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_italian_professional }}

Description of Device: {{ device_description_italian_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_italian_professional }} {{ material1_percentage_italian_professional }}
{{ material2_name_italian_professional }} {{ material2_percentage_italian_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_italian_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_italian_professional }}

Sterilization Information: {{ sterilization_info_italian_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_italian_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_italian_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_italian_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_italian_professional }}

{% for risk in residual_risk_quantification_italian_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_italian_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_italian_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_italian_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_italian_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_italian_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_italian_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_italian_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_italian_professional }}

{% for outcome in performance_outcomes_italian_professional %} {% endfor %} {% for outcome in safety_outcomes_italian_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_italian_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_italian_professional }}

{% for therapy in therapeutic_alternatives_italian_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_italian_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_italian_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_italian_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Italian {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_italian_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_italian_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_italian_patient }}

Manufacturer Name and Address: {{ manufacturer_info_italian_patient }}

Basic UDI-DI: {{ basic_udi_di_italian_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_italian_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_italian_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_italian_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_italian_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_italian_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_italian_patient }}

Indication(s): {{ indications_italian_patient }}

Target Population(s): {{ target_populations_italian_patient }}

Contraindications and/or Limitations: {{ contraindications_italian_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_italian_patient }}

Description of Device: {{ device_description_italian_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_italian_patient }} {{ material1_percentage_italian_patient }}
{{ material2_name_italian_patient }} {{ material2_percentage_italian_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_italian_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_italian_patient }}

Sterilization Information: {{ sterilization_info_italian_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_italian_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_italian_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_italian_patient }}

{% for risk in remaining_risks_table_italian_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_italian_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_italian_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_italian_patient }}

Safety

{{ safety_summary_italian_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_italian_patient }}

{% for therapy in therapeutic_alternatives_italian_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_italian_patient }}

Acronyms

{% for acronym in acronyms_italian_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_lithuanian_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_lithuanian_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_lithuanian_professional }}

Manufacturer Name and Address: {{ manufacturer_info_lithuanian_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_lithuanian_professional }}

Basic UDI-DI: {{ basic_udi_di_lithuanian_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_lithuanian_professional }}

Class of Device: {{ class_of_device_lithuanian_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_lithuanian_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_lithuanian_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_lithuanian_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_lithuanian_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_lithuanian_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_lithuanian_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_lithuanian_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_lithuanian_professional }}

Indication(s): {{ indications_lithuanian_professional }}

Target Population(s): {{ target_populations_lithuanian_professional }}

Contraindications and/or Limitations: {{ contraindications_lithuanian_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_lithuanian_professional }}

Description of Device: {{ device_description_lithuanian_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_lithuanian_professional }} {{ material1_percentage_lithuanian_professional }}
{{ material2_name_lithuanian_professional }} {{ material2_percentage_lithuanian_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_lithuanian_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_lithuanian_professional }}

Sterilization Information: {{ sterilization_info_lithuanian_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_lithuanian_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_lithuanian_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_lithuanian_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_lithuanian_professional }}

{% for risk in residual_risk_quantification_lithuanian_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_lithuanian_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_lithuanian_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_lithuanian_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_lithuanian_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_lithuanian_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_lithuanian_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_lithuanian_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_lithuanian_professional }}

{% for outcome in performance_outcomes_lithuanian_professional %} {% endfor %} {% for outcome in safety_outcomes_lithuanian_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_lithuanian_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_lithuanian_professional }}

{% for therapy in therapeutic_alternatives_lithuanian_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_lithuanian_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_lithuanian_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_lithuanian_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Lithuanian {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_lithuanian_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_lithuanian_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_lithuanian_patient }}

Manufacturer Name and Address: {{ manufacturer_info_lithuanian_patient }}

Basic UDI-DI: {{ basic_udi_di_lithuanian_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_lithuanian_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_lithuanian_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_lithuanian_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_lithuanian_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_lithuanian_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_lithuanian_patient }}

Indication(s): {{ indications_lithuanian_patient }}

Target Population(s): {{ target_populations_lithuanian_patient }}

Contraindications and/or Limitations: {{ contraindications_lithuanian_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_lithuanian_patient }}

Description of Device: {{ device_description_lithuanian_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_lithuanian_patient }} {{ material1_percentage_lithuanian_patient }}
{{ material2_name_lithuanian_patient }} {{ material2_percentage_lithuanian_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_lithuanian_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_lithuanian_patient }}

Sterilization Information: {{ sterilization_info_lithuanian_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_lithuanian_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_lithuanian_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_lithuanian_patient }}

{% for risk in remaining_risks_table_lithuanian_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_lithuanian_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_lithuanian_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_lithuanian_patient }}

Safety

{{ safety_summary_lithuanian_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_lithuanian_patient }}

{% for therapy in therapeutic_alternatives_lithuanian_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_lithuanian_patient }}

Acronyms

{% for acronym in acronyms_lithuanian_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_latvian_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_latvian_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_latvian_professional }}

Manufacturer Name and Address: {{ manufacturer_info_latvian_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_latvian_professional }}

Basic UDI-DI: {{ basic_udi_di_latvian_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_latvian_professional }}

Class of Device: {{ class_of_device_latvian_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_latvian_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_latvian_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_latvian_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_latvian_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_latvian_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_latvian_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_latvian_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_latvian_professional }}

Indication(s): {{ indications_latvian_professional }}

Target Population(s): {{ target_populations_latvian_professional }}

Contraindications and/or Limitations: {{ contraindications_latvian_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_latvian_professional }}

Description of Device: {{ device_description_latvian_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_latvian_professional }} {{ material1_percentage_latvian_professional }}
{{ material2_name_latvian_professional }} {{ material2_percentage_latvian_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_latvian_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_latvian_professional }}

Sterilization Information: {{ sterilization_info_latvian_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_latvian_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_latvian_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_latvian_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_latvian_professional }}

{% for risk in residual_risk_quantification_latvian_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_latvian_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_latvian_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_latvian_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_latvian_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_latvian_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_latvian_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_latvian_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_latvian_professional }}

{% for outcome in performance_outcomes_latvian_professional %} {% endfor %} {% for outcome in safety_outcomes_latvian_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_latvian_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_latvian_professional }}

{% for therapy in therapeutic_alternatives_latvian_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_latvian_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_latvian_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_latvian_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Latvian {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_latvian_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_latvian_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_latvian_patient }}

Manufacturer Name and Address: {{ manufacturer_info_latvian_patient }}

Basic UDI-DI: {{ basic_udi_di_latvian_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_latvian_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_latvian_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_latvian_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_latvian_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_latvian_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_latvian_patient }}

Indication(s): {{ indications_latvian_patient }}

Target Population(s): {{ target_populations_latvian_patient }}

Contraindications and/or Limitations: {{ contraindications_latvian_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_latvian_patient }}

Description of Device: {{ device_description_latvian_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_latvian_patient }} {{ material1_percentage_latvian_patient }}
{{ material2_name_latvian_patient }} {{ material2_percentage_latvian_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_latvian_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_latvian_patient }}

Sterilization Information: {{ sterilization_info_latvian_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_latvian_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_latvian_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_latvian_patient }}

{% for risk in remaining_risks_table_latvian_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_latvian_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_latvian_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_latvian_patient }}

Safety

{{ safety_summary_latvian_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_latvian_patient }}

{% for therapy in therapeutic_alternatives_latvian_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_latvian_patient }}

Acronyms

{% for acronym in acronyms_latvian_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_dutch_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_dutch_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_dutch_professional }}

Manufacturer Name and Address: {{ manufacturer_info_dutch_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_dutch_professional }}

Basic UDI-DI: {{ basic_udi_di_dutch_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_dutch_professional }}

Class of Device: {{ class_of_device_dutch_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_dutch_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_dutch_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_dutch_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_dutch_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_dutch_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_dutch_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_dutch_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_dutch_professional }}

Indication(s): {{ indications_dutch_professional }}

Target Population(s): {{ target_populations_dutch_professional }}

Contraindications and/or Limitations: {{ contraindications_dutch_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_dutch_professional }}

Description of Device: {{ device_description_dutch_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_dutch_professional }} {{ material1_percentage_dutch_professional }}
{{ material2_name_dutch_professional }} {{ material2_percentage_dutch_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_dutch_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_dutch_professional }}

Sterilization Information: {{ sterilization_info_dutch_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_dutch_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_dutch_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_dutch_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_dutch_professional }}

{% for risk in residual_risk_quantification_dutch_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_dutch_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_dutch_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_dutch_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_dutch_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_dutch_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_dutch_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_dutch_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_dutch_professional }}

{% for outcome in performance_outcomes_dutch_professional %} {% endfor %} {% for outcome in safety_outcomes_dutch_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_dutch_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_dutch_professional }}

{% for therapy in therapeutic_alternatives_dutch_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_dutch_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_dutch_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_dutch_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Dutch {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_dutch_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_dutch_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_dutch_patient }}

Manufacturer Name and Address: {{ manufacturer_info_dutch_patient }}

Basic UDI-DI: {{ basic_udi_di_dutch_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_dutch_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_dutch_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_dutch_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_dutch_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_dutch_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_dutch_patient }}

Indication(s): {{ indications_dutch_patient }}

Target Population(s): {{ target_populations_dutch_patient }}

Contraindications and/or Limitations: {{ contraindications_dutch_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_dutch_patient }}

Description of Device: {{ device_description_dutch_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_dutch_patient }} {{ material1_percentage_dutch_patient }}
{{ material2_name_dutch_patient }} {{ material2_percentage_dutch_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_dutch_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_dutch_patient }}

Sterilization Information: {{ sterilization_info_dutch_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_dutch_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_dutch_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_dutch_patient }}

{% for risk in remaining_risks_table_dutch_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_dutch_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_dutch_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_dutch_patient }}

Safety

{{ safety_summary_dutch_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_dutch_patient }}

{% for therapy in therapeutic_alternatives_dutch_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_dutch_patient }}

Acronyms

{% for acronym in acronyms_dutch_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_finnish_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_finnish_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_finnish_professional }}

Manufacturer Name and Address: {{ manufacturer_info_finnish_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_finnish_professional }}

Basic UDI-DI: {{ basic_udi_di_finnish_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_finnish_professional }}

Class of Device: {{ class_of_device_finnish_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_finnish_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_finnish_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_finnish_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_finnish_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_finnish_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_finnish_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_finnish_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_finnish_professional }}

Indication(s): {{ indications_finnish_professional }}

Target Population(s): {{ target_populations_finnish_professional }}

Contraindications and/or Limitations: {{ contraindications_finnish_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_finnish_professional }}

Description of Device: {{ device_description_finnish_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_finnish_professional }} {{ material1_percentage_finnish_professional }}
{{ material2_name_finnish_professional }} {{ material2_percentage_finnish_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_finnish_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_finnish_professional }}

Sterilization Information: {{ sterilization_info_finnish_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_finnish_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_finnish_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_finnish_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_finnish_professional }}

{% for risk in residual_risk_quantification_finnish_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_finnish_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_finnish_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_finnish_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_finnish_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_finnish_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_finnish_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_finnish_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_finnish_professional }}

{% for outcome in performance_outcomes_finnish_professional %} {% endfor %} {% for outcome in safety_outcomes_finnish_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_finnish_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_finnish_professional }}

{% for therapy in therapeutic_alternatives_finnish_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_finnish_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_finnish_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_finnish_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Finnish {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_finnish_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_finnish_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_finnish_patient }}

Manufacturer Name and Address: {{ manufacturer_info_finnish_patient }}

Basic UDI-DI: {{ basic_udi_di_finnish_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_finnish_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_finnish_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_finnish_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_finnish_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_finnish_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_finnish_patient }}

Indication(s): {{ indications_finnish_patient }}

Target Population(s): {{ target_populations_finnish_patient }}

Contraindications and/or Limitations: {{ contraindications_finnish_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_finnish_patient }}

Description of Device: {{ device_description_finnish_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_finnish_patient }} {{ material1_percentage_finnish_patient }}
{{ material2_name_finnish_patient }} {{ material2_percentage_finnish_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_finnish_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_finnish_patient }}

Sterilization Information: {{ sterilization_info_finnish_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_finnish_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_finnish_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_finnish_patient }}

{% for risk in remaining_risks_table_finnish_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_finnish_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_finnish_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_finnish_patient }}

Safety

{{ safety_summary_finnish_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_finnish_patient }}

{% for therapy in therapeutic_alternatives_finnish_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_finnish_patient }}

Acronyms

{% for acronym in acronyms_finnish_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_polish_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_polish_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_polish_professional }}

Manufacturer Name and Address: {{ manufacturer_info_polish_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_polish_professional }}

Basic UDI-DI: {{ basic_udi_di_polish_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_polish_professional }}

Class of Device: {{ class_of_device_polish_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_polish_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_polish_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_polish_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_polish_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_polish_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_polish_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_polish_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_polish_professional }}

Indication(s): {{ indications_polish_professional }}

Target Population(s): {{ target_populations_polish_professional }}

Contraindications and/or Limitations: {{ contraindications_polish_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_polish_professional }}

Description of Device: {{ device_description_polish_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_polish_professional }} {{ material1_percentage_polish_professional }}
{{ material2_name_polish_professional }} {{ material2_percentage_polish_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_polish_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_polish_professional }}

Sterilization Information: {{ sterilization_info_polish_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_polish_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_polish_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_polish_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_polish_professional }}

{% for risk in residual_risk_quantification_polish_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_polish_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_polish_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_polish_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_polish_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_polish_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_polish_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_polish_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_polish_professional }}

{% for outcome in performance_outcomes_polish_professional %} {% endfor %} {% for outcome in safety_outcomes_polish_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_polish_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_polish_professional }}

{% for therapy in therapeutic_alternatives_polish_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_polish_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_polish_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_polish_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Polish {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_polish_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_polish_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_polish_patient }}

Manufacturer Name and Address: {{ manufacturer_info_polish_patient }}

Basic UDI-DI: {{ basic_udi_di_polish_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_polish_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_polish_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_polish_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_polish_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_polish_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_polish_patient }}

Indication(s): {{ indications_polish_patient }}

Target Population(s): {{ target_populations_polish_patient }}

Contraindications and/or Limitations: {{ contraindications_polish_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_polish_patient }}

Description of Device: {{ device_description_polish_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_polish_patient }} {{ material1_percentage_polish_patient }}
{{ material2_name_polish_patient }} {{ material2_percentage_polish_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_polish_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_polish_patient }}

Sterilization Information: {{ sterilization_info_polish_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_polish_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_polish_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_polish_patient }}

{% for risk in remaining_risks_table_polish_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_polish_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_polish_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_polish_patient }}

Safety

{{ safety_summary_polish_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_polish_patient }}

{% for therapy in therapeutic_alternatives_polish_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_polish_patient }}

Acronyms

{% for acronym in acronyms_polish_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_portuguese_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_portuguese_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_portuguese_professional }}

Manufacturer Name and Address: {{ manufacturer_info_portuguese_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_portuguese_professional }}

Basic UDI-DI: {{ basic_udi_di_portuguese_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_portuguese_professional }}

Class of Device: {{ class_of_device_portuguese_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_portuguese_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_portuguese_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_portuguese_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_portuguese_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_portuguese_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_portuguese_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_portuguese_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_portuguese_professional }}

Indication(s): {{ indications_portuguese_professional }}

Target Population(s): {{ target_populations_portuguese_professional }}

Contraindications and/or Limitations: {{ contraindications_portuguese_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_portuguese_professional }}

Description of Device: {{ device_description_portuguese_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_portuguese_professional }} {{ material1_percentage_portuguese_professional }}
{{ material2_name_portuguese_professional }} {{ material2_percentage_portuguese_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_portuguese_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_portuguese_professional }}

Sterilization Information: {{ sterilization_info_portuguese_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_portuguese_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_portuguese_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_portuguese_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_portuguese_professional }}

{% for risk in residual_risk_quantification_portuguese_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_portuguese_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_portuguese_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_portuguese_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_portuguese_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_portuguese_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_portuguese_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_portuguese_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_portuguese_professional }}

{% for outcome in performance_outcomes_portuguese_professional %} {% endfor %} {% for outcome in safety_outcomes_portuguese_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_portuguese_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_portuguese_professional }}

{% for therapy in therapeutic_alternatives_portuguese_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_portuguese_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_portuguese_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_portuguese_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Portuguese {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_portuguese_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_portuguese_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_portuguese_patient }}

Manufacturer Name and Address: {{ manufacturer_info_portuguese_patient }}

Basic UDI-DI: {{ basic_udi_di_portuguese_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_portuguese_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_portuguese_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_portuguese_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_portuguese_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_portuguese_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_portuguese_patient }}

Indication(s): {{ indications_portuguese_patient }}

Target Population(s): {{ target_populations_portuguese_patient }}

Contraindications and/or Limitations: {{ contraindications_portuguese_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_portuguese_patient }}

Description of Device: {{ device_description_portuguese_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_portuguese_patient }} {{ material1_percentage_portuguese_patient }}
{{ material2_name_portuguese_patient }} {{ material2_percentage_portuguese_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_portuguese_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_portuguese_patient }}

Sterilization Information: {{ sterilization_info_portuguese_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_portuguese_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_portuguese_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_portuguese_patient }}

{% for risk in remaining_risks_table_portuguese_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_portuguese_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_portuguese_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_portuguese_patient }}

Safety

{{ safety_summary_portuguese_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_portuguese_patient }}

{% for therapy in therapeutic_alternatives_portuguese_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_portuguese_patient }}

Acronyms

{% for acronym in acronyms_portuguese_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_romanian_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_romanian_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_romanian_professional }}

Manufacturer Name and Address: {{ manufacturer_info_romanian_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_romanian_professional }}

Basic UDI-DI: {{ basic_udi_di_romanian_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_romanian_professional }}

Class of Device: {{ class_of_device_romanian_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_romanian_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_romanian_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_romanian_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_romanian_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_romanian_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_romanian_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_romanian_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_romanian_professional }}

Indication(s): {{ indications_romanian_professional }}

Target Population(s): {{ target_populations_romanian_professional }}

Contraindications and/or Limitations: {{ contraindications_romanian_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_romanian_professional }}

Description of Device: {{ device_description_romanian_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_romanian_professional }} {{ material1_percentage_romanian_professional }}
{{ material2_name_romanian_professional }} {{ material2_percentage_romanian_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_romanian_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_romanian_professional }}

Sterilization Information: {{ sterilization_info_romanian_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_romanian_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_romanian_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_romanian_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_romanian_professional }}

{% for risk in residual_risk_quantification_romanian_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_romanian_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_romanian_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_romanian_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_romanian_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_romanian_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_romanian_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_romanian_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_romanian_professional }}

{% for outcome in performance_outcomes_romanian_professional %} {% endfor %} {% for outcome in safety_outcomes_romanian_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_romanian_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_romanian_professional }}

{% for therapy in therapeutic_alternatives_romanian_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_romanian_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_romanian_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_romanian_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Romanian {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_romanian_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_romanian_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_romanian_patient }}

Manufacturer Name and Address: {{ manufacturer_info_romanian_patient }}

Basic UDI-DI: {{ basic_udi_di_romanian_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_romanian_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_romanian_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_romanian_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_romanian_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_romanian_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_romanian_patient }}

Indication(s): {{ indications_romanian_patient }}

Target Population(s): {{ target_populations_romanian_patient }}

Contraindications and/or Limitations: {{ contraindications_romanian_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_romanian_patient }}

Description of Device: {{ device_description_romanian_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_romanian_patient }} {{ material1_percentage_romanian_patient }}
{{ material2_name_romanian_patient }} {{ material2_percentage_romanian_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_romanian_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_romanian_patient }}

Sterilization Information: {{ sterilization_info_romanian_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_romanian_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_romanian_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_romanian_patient }}

{% for risk in remaining_risks_table_romanian_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_romanian_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_romanian_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_romanian_patient }}

Safety

{{ safety_summary_romanian_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_romanian_patient }}

{% for therapy in therapeutic_alternatives_romanian_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_romanian_patient }}

Acronyms

{% for acronym in acronyms_romanian_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_slovak_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_slovak_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_slovak_professional }}

Manufacturer Name and Address: {{ manufacturer_info_slovak_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_slovak_professional }}

Basic UDI-DI: {{ basic_udi_di_slovak_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_slovak_professional }}

Class of Device: {{ class_of_device_slovak_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_slovak_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_slovak_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_slovak_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_slovak_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_slovak_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_slovak_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_slovak_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_slovak_professional }}

Indication(s): {{ indications_slovak_professional }}

Target Population(s): {{ target_populations_slovak_professional }}

Contraindications and/or Limitations: {{ contraindications_slovak_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_slovak_professional }}

Description of Device: {{ device_description_slovak_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_slovak_professional }} {{ material1_percentage_slovak_professional }}
{{ material2_name_slovak_professional }} {{ material2_percentage_slovak_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_slovak_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_slovak_professional }}

Sterilization Information: {{ sterilization_info_slovak_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_slovak_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_slovak_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_slovak_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_slovak_professional }}

{% for risk in residual_risk_quantification_slovak_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_slovak_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_slovak_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_slovak_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_slovak_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_slovak_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_slovak_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_slovak_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_slovak_professional }}

{% for outcome in performance_outcomes_slovak_professional %} {% endfor %} {% for outcome in safety_outcomes_slovak_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_slovak_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_slovak_professional }}

{% for therapy in therapeutic_alternatives_slovak_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_slovak_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_slovak_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_slovak_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Slovak {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_slovak_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_slovak_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_slovak_patient }}

Manufacturer Name and Address: {{ manufacturer_info_slovak_patient }}

Basic UDI-DI: {{ basic_udi_di_slovak_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_slovak_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_slovak_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_slovak_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_slovak_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_slovak_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_slovak_patient }}

Indication(s): {{ indications_slovak_patient }}

Target Population(s): {{ target_populations_slovak_patient }}

Contraindications and/or Limitations: {{ contraindications_slovak_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_slovak_patient }}

Description of Device: {{ device_description_slovak_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_slovak_patient }} {{ material1_percentage_slovak_patient }}
{{ material2_name_slovak_patient }} {{ material2_percentage_slovak_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_slovak_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_slovak_patient }}

Sterilization Information: {{ sterilization_info_slovak_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_slovak_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_slovak_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_slovak_patient }}

{% for risk in remaining_risks_table_slovak_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_slovak_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_slovak_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_slovak_patient }}

Safety

{{ safety_summary_slovak_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_slovak_patient }}

{% for therapy in therapeutic_alternatives_slovak_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_slovak_patient }}

Acronyms

{% for acronym in acronyms_slovak_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_slovenian_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_slovenian_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_slovenian_professional }}

Manufacturer Name and Address: {{ manufacturer_info_slovenian_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_slovenian_professional }}

Basic UDI-DI: {{ basic_udi_di_slovenian_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_slovenian_professional }}

Class of Device: {{ class_of_device_slovenian_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_slovenian_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_slovenian_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_slovenian_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_slovenian_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_slovenian_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_slovenian_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_slovenian_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_slovenian_professional }}

Indication(s): {{ indications_slovenian_professional }}

Target Population(s): {{ target_populations_slovenian_professional }}

Contraindications and/or Limitations: {{ contraindications_slovenian_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_slovenian_professional }}

Description of Device: {{ device_description_slovenian_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_slovenian_professional }} {{ material1_percentage_slovenian_professional }}
{{ material2_name_slovenian_professional }} {{ material2_percentage_slovenian_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_slovenian_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_slovenian_professional }}

Sterilization Information: {{ sterilization_info_slovenian_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_slovenian_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_slovenian_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_slovenian_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_slovenian_professional }}

{% for risk in residual_risk_quantification_slovenian_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_slovenian_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_slovenian_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_slovenian_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_slovenian_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_slovenian_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_slovenian_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_slovenian_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_slovenian_professional }}

{% for outcome in performance_outcomes_slovenian_professional %} {% endfor %} {% for outcome in safety_outcomes_slovenian_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_slovenian_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_slovenian_professional }}

{% for therapy in therapeutic_alternatives_slovenian_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_slovenian_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_slovenian_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_slovenian_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Slovenian {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_slovenian_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_slovenian_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_slovenian_patient }}

Manufacturer Name and Address: {{ manufacturer_info_slovenian_patient }}

Basic UDI-DI: {{ basic_udi_di_slovenian_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_slovenian_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_slovenian_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_slovenian_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_slovenian_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_slovenian_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_slovenian_patient }}

Indication(s): {{ indications_slovenian_patient }}

Target Population(s): {{ target_populations_slovenian_patient }}

Contraindications and/or Limitations: {{ contraindications_slovenian_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_slovenian_patient }}

Description of Device: {{ device_description_slovenian_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_slovenian_patient }} {{ material1_percentage_slovenian_patient }}
{{ material2_name_slovenian_patient }} {{ material2_percentage_slovenian_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_slovenian_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_slovenian_patient }}

Sterilization Information: {{ sterilization_info_slovenian_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_slovenian_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_slovenian_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_slovenian_patient }}

{% for risk in remaining_risks_table_slovenian_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_slovenian_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_slovenian_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_slovenian_patient }}

Safety

{{ safety_summary_slovenian_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_slovenian_patient }}

{% for therapy in therapeutic_alternatives_slovenian_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_slovenian_patient }}

Acronyms

{% for acronym in acronyms_slovenian_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_swedish_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_swedish_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_swedish_professional }}

Manufacturer Name and Address: {{ manufacturer_info_swedish_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_swedish_professional }}

Basic UDI-DI: {{ basic_udi_di_swedish_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_swedish_professional }}

Class of Device: {{ class_of_device_swedish_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_swedish_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_swedish_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_swedish_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_swedish_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_swedish_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_swedish_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_swedish_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_swedish_professional }}

Indication(s): {{ indications_swedish_professional }}

Target Population(s): {{ target_populations_swedish_professional }}

Contraindications and/or Limitations: {{ contraindications_swedish_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_swedish_professional }}

Description of Device: {{ device_description_swedish_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_swedish_professional }} {{ material1_percentage_swedish_professional }}
{{ material2_name_swedish_professional }} {{ material2_percentage_swedish_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_swedish_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_swedish_professional }}

Sterilization Information: {{ sterilization_info_swedish_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_swedish_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_swedish_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_swedish_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_swedish_professional }}

{% for risk in residual_risk_quantification_swedish_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_swedish_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_swedish_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_swedish_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_swedish_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_swedish_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_swedish_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_swedish_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_swedish_professional }}

{% for outcome in performance_outcomes_swedish_professional %} {% endfor %} {% for outcome in safety_outcomes_swedish_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_swedish_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_swedish_professional }}

{% for therapy in therapeutic_alternatives_swedish_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_swedish_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_swedish_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_swedish_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Swedish {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_swedish_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_swedish_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_swedish_patient }}

Manufacturer Name and Address: {{ manufacturer_info_swedish_patient }}

Basic UDI-DI: {{ basic_udi_di_swedish_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_swedish_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_swedish_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_swedish_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_swedish_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_swedish_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_swedish_patient }}

Indication(s): {{ indications_swedish_patient }}

Target Population(s): {{ target_populations_swedish_patient }}

Contraindications and/or Limitations: {{ contraindications_swedish_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_swedish_patient }}

Description of Device: {{ device_description_swedish_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_swedish_patient }} {{ material1_percentage_swedish_patient }}
{{ material2_name_swedish_patient }} {{ material2_percentage_swedish_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_swedish_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_swedish_patient }}

Sterilization Information: {{ sterilization_info_swedish_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_swedish_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_swedish_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_swedish_patient }}

{% for risk in remaining_risks_table_swedish_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_swedish_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_swedish_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_swedish_patient }}

Safety

{{ safety_summary_swedish_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_swedish_patient }}

{% for therapy in therapeutic_alternatives_swedish_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_swedish_patient }}

Acronyms

{% for acronym in acronyms_swedish_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}

Summary of Safety and Clinical Performance

{{ device_trade_names_turkish_professional }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_turkish_professional }}

Applicable Documents

Document Type Document Title / Number
Design History File (DHF) {{ dhf_document }}
‘MDR Documentation’ File Number {{ mdr_document }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_turkish_professional }}

Manufacturer Name and Address: {{ manufacturer_info_turkish_professional }}

Manufacturer Single Registration Number (SRN): {{ manufacturer_srn_turkish_professional }}

Basic UDI-DI: {{ basic_udi_di_turkish_professional }}

Medical Device Nomenclature: {{ medical_device_nomenclature_turkish_professional }}

Class of Device: {{ class_of_device_turkish_professional }}

Date First CE Certificate Issued: {{ ce_certificate_date_turkish_professional }}

Authorized Representative Name and SRN: {{ auth_rep_srn_turkish_professional }}

Notified Body Name and Single Identification Number: {{ notified_body_info_turkish_professional }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_turkish_professional }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_turkish_professional %} {% endfor %}
Variant Description Part Number(s) Explanation of Multiple Part Numbers
{{ variant.description }} {{ variant.part_numbers }} {{ variant.explanation }}

Procedure Trays:

{% for tray in procedure_trays_turkish_professional %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_turkish_professional %} {% endfor %}
Configuration Type Kit Components
{{ config.type }} {{ config.components | join(', ') }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_turkish_professional }}

Indication(s): {{ indications_turkish_professional }}

Target Population(s): {{ target_populations_turkish_professional }}

Contraindications and/or Limitations: {{ contraindications_turkish_professional }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_turkish_professional }}

Description of Device: {{ device_description_turkish_professional }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_turkish_professional }} {{ material1_percentage_turkish_professional }}
{{ material2_name_turkish_professional }} {{ material2_percentage_turkish_professional }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_turkish_professional }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_turkish_professional }}

Sterilization Information: {{ sterilization_info_turkish_professional }}

Previous Generations / Variants:

{% for generation in previous_generations_turkish_professional %} {% endfor %}
Name of Previous Generation Differences from Current Device
{{ generation.name }} {{ generation.differences }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_turkish_professional %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Other Devices or Products Intended for Use in Combination with the Device:

{% for product in combination_devices_turkish_professional %} {% endfor %}
Name of Device or Product Description of Device or Product
{{ product.name }} {{ product.description }}

Risks and Warnings

Residual Risks and Undesirable Effects: {{ residual_risks_turkish_professional }}

{% for risk in residual_risk_quantification_turkish_professional %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
Units Sold Units Studied
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Warnings and Precautions: {{ warnings_turkish_professional }}

Other Relevant Aspects of Safety: {{ pms_summary_turkish_professional }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF)

Summary of Clinical Data Related to Subject Device

{% for case in clinical_data_subject_device_turkish_professional %} {% endfor %}
Specific Case Numbers (Mixed Cohort Case Numbers) Identified and Used for Clinical Performance Evaluation
Clinical Literature PMCF Data Total Cases User Survey Responses
{{ case.clinical_literature }} {{ case.pmcf_data }} {{ case.total_cases }} {{ case.user_survey_responses }}

{{ clinical_data_subject_device_summary_turkish_professional }}

Summary of Clinical Data Related to the Equivalent Device

{{ clinical_data_equivalent_device_turkish_professional }}

Summary of Clinical Data from Pre-Market Investigations (if applicable)

{{ clinical_data_pre_market_turkish_professional }}

Summary of Clinical Data from Other Sources

{% for source in clinical_data_other_sources_turkish_professional %}

Source: {{ source.name }}

{{ source.description }}

{% endfor %}

Overall Summary of Clinical Safety and Performance

{{ overall_clinical_summary_turkish_professional }}

{% for outcome in performance_outcomes_turkish_professional %} {% endfor %} {% for outcome in safety_outcomes_turkish_professional %} {% endfor %}
Outcome
Performance
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}
Safety
Outcome Benefit/Risk Acceptability Criteria Desired Trend Clinical Literature (Subject Device) PMCF Data (Subject Device)
{{ outcome.outcome }} {{ outcome.benefit_risk_criteria }} {{ outcome.desired_trend }} {{ outcome.clinical_literature }} {{ outcome.pmcf_data }}

On-going or Planned Post-Market Clinical Follow-up (PMCF)

{% for activity in pmcf_activities_turkish_professional %} {% endfor %}
Activity Description Reference Timeline
{{ activity.name }} {{ activity.description }} {{ activity.reference }} {{ activity.timeline }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_turkish_professional }}

{% for therapy in therapeutic_alternatives_turkish_professional %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_turkish_professional }}

Reference to Any Harmonized Standards and Common Specifications (CS) Applied

{% for standard in harmonized_standards_turkish_professional %} {% endfor %}
Harmonized Standard or CS Revision Title or Description Level of Compliance
{{ standard.standard }} {{ standard.revision }} {{ standard.title }} {{ standard.compliance }}

Revision History

{% for revision in revision_history_turkish_professional %} {% endfor %}
Revision Date CR# Author Description of Changes Validated
{{ revision.revision }} {{ revision.date }} {{ revision.cr_number }} {{ revision.author }} {{ revision.description }} {% if revision.validated == "yes" %} Yes, this version was validated by the Notified Body in the following language: Turkish {% else %} No, this version was not validated by the Notified Body as this is a Class IIa or IIb implantable device {% endif %}

Summary of Safety and Clinical Performance

{{ device_trade_names_turkish_patient }}

SSCP Document Number: {{ sscpnumber }}

Important Information

{{ important_information_turkish_patient }}

Device Identification and General Information

Device Trade Name(s): {{ device_trade_names_turkish_patient }}

Manufacturer Name and Address: {{ manufacturer_info_turkish_patient }}

Basic UDI-DI: {{ basic_udi_di_turkish_patient }}

Date First CE Certificate Was Issued for This Device: {{ ce_certificate_date_turkish_patient }}

Device Grouping and Variants

The devices in scope of this document are all {{ reason_for_grouping_turkish_patient }}. The device part numbers are organized into variant categories. These devices are distributed as procedure trays, in various configurations inclusive of accessories and adjunctive devices (see section "Accessories intended for use in combination with the Device").

Variant Devices:

{% for variant in variant_devices_turkish_patient %} {% endfor %}
Variant Description Part Number(s)
{{ variant.description }} {{ variant.part_numbers }}

Procedure Trays:

{% for tray in procedure_trays_turkish_patient %} {% endfor %}
Catalog Code Part Number Description
{{ tray.catalog_code }} {{ tray.part_number }} {{ tray.description }}

Configurations of Procedure Trays:

{% for config in configurations_turkish_patient %} {% endfor %}
Configuration Type
{{ config.type }}

Intended Use of the Device

Intended Purpose: {{ intended_purpose_turkish_patient }}

Indication(s): {{ indications_turkish_patient }}

Target Population(s): {{ target_populations_turkish_patient }}

Contraindications and/or Limitations: {{ contraindications_turkish_patient }}

Device Description

IMAGES OF DEVICE

Device Name: {{ device_name_turkish_patient }}

Description of Device: {{ device_description_turkish_patient }}

Materials / Substances in Contact with Patient Tissue:

Material % Weight (w/w)
{{ material1_name_turkish_patient }} {{ material1_percentage_turkish_patient }}
{{ material2_name_turkish_patient }} {{ material2_percentage_turkish_patient }}

Information on Medicinal Substances in the Device: {{ medicinal_substances_info_turkish_patient }}

How the Device Achieves its Intended Mode of Action: {{ mode_of_action_turkish_patient }}

Sterilization Information: {{ sterilization_info_turkish_patient }}

Accessories Intended for Use in Combination with the Device:

{% for accessory in accessories_turkish_patient %} {% endfor %}
Name of Accessory Description of Accessory
{{ accessory.name }} {{ accessory.description }}

Risks and Warnings

How Potential Risks Have Been Controlled or Managed

{{ how_risks_controlled_turkish_patient }}

Remaining Risks and Undesirable Effects

{{ remaining_risks_text_turkish_patient }}

{% for risk in remaining_risks_table_turkish_patient %} {% endfor %}
Patient Residual Harm Category Quantification of Residual Risks
PMS Complaints PMCF Events
# of Cases Per Event # of Cases Per Event
{{ risk.harm_category }} {{ risk.pms_complaints }} {{ risk.pmcf_events }}

Summary of Any Field Safety Correction Action (FSCA)

{{ fsca_summary_turkish_patient }}

Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

{{ clinical_background_turkish_patient }}

Clinical Evidence for CE-Marking

{{ clinical_evidence_ce_marking_turkish_patient }}

Safety

{{ safety_summary_turkish_patient }}

Possible Therapeutic Alternatives

{{ possible_therapeutic_alternatives_text_turkish_patient }}

{% for therapy in therapeutic_alternatives_turkish_patient %} {% endfor %}
Therapy Benefits Disadvantages Key Risks
{{ therapy.therapy }} {{ therapy.benefits }} {{ therapy.disadvantages }} {{ therapy.key_risks }}

Suggested Profile and Training for Users

{{ suggested_profile_training_text_turkish_patient }}

Acronyms

{% for acronym in acronyms_turkish_patient %} {% endfor %}
Abbreviation Definition
{{ acronym.abbreviation }} {{ acronym.definition }}