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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replacement
Regulation Description Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
Definition To repair or replace chordae tendinae.
Product CodePAW
Regulation Number 870.3470
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2023 1 1
2024 2 2
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Mitral Regurgitation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hemorrhage/Bleeding 1 1
Mitral Valve Insufficiency/ Regurgitation 1 1
Arrhythmia 1 1
Foreign Body In Patient 1 1
Mitral Valve Prolapse 1 1

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