Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 878 - GENERAL AND PLASTIC SURGERY DEVICES
/ Subpart E - Surgical Devices / § 878.4520 Polytetrafluoroethylene injectable.
§ 878.4520 Polytetrafluoroethylene injectable.
(a) Identification. Polytetrafluoroethylene injectable is an injectable paste prosthetic device composed of polytetrafluoroethylene intended to be used to augment or reconstruct a vocal cord.
(b) Classification. Class III.
(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.