---
kind: "section"
citation: "21 C.F.R. § 870.3470"
title: "21"
number: "870.3470"
heading: "Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene."
url: "https://uscodex.org/cfr/21/870.3470"
---

# §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).

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.