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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device intracardiac patch or pledget, biologically derived
Regulation Description Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
Definition To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.
Product CodePSQ
Regulation Number 870.3470
Device Class 2

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