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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
Definition To repair or replace chordae tendinae.
Product CodePAW
Regulation Number 878.5035
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Mitral Regurgitation 1 1
Mitral Valve Prolapse 1 1

Recalls
Manufacturer Recall Class Date Posted
1 On-X Life Technologies, Inc. II Jan-20-2017
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