StacksVerified U.S. regulatory reference

21 CFR §878.4520

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. Polytetrafluoroethylene injectable is an injectable paste prosthetic device composed of polytetrafluoroethylene intended to be used to augment or reconstruct a vocal cord.
  2. (b)Classification. Class III.
  3. (c)Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3.