§ 870.3470. Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
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/us/cfr/t21/s§ 870.3470·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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).