Code of Federal Regulations · Section

§ 870.3470 — Intracardiac Patch Or Pledget Made Of Polypropylene, Polyethylene Terephthalate, Or Polytetrafluoroethylene

21 C.F.R. § 870.3470

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(a) Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

(b) Classification. Class II (performance standards).

21 C.F.R. § 870.3460 21 C.F.R. § 870.3535

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