{"data":{"id":"us/21-cfr-878.4520","jurisdiction":"us","citation":"21 CFR 878.4520","heading":"Polytetrafluoroethylene injectable.","body":"(a) Identification. Polytetrafluoroethylene injectable is an injectable paste prosthetic device composed of polytetrafluoroethylene intended to be used to augment or reconstruct a vocal cord.\n(b) Classification. Class III.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 878—GENERAL AND PLASTIC SURGERY DEVICES","Subpart E—Surgical Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"2a50d0a275eaa2d30e4305303ca2ae9a975104a911e9ef2c1994332ec31fa7b2","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.4495","next":"us/21-cfr-878.4550"},"notice":"GroundRules: Original legal text. Not legal advice."}