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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


Premarket Reviews
ManufacturerDecision
CHAWLA HEART TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1

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