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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pericardial patch to facilitate revision surgeries
Regulation Description Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
Definition Pericardial patch or pledget with the secondary function of facilitating revision surgeries by providing a plane of dissection. Does not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of cardiac surgery.
Product CodeOMH
Regulation Number 870.3470
Device Class 2


Premarket Reviews
ManufacturerDecision
MACROPORE BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 1

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