21 C.F.R. § 870.3470

Current through November 30, 2024
Section 870.3470 - Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene
(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. § 870.3470