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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
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

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