21 CFR 878.4520
§ 878.4520 Polytetrafluoroethylene injectable.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 878.4520, § 878.4520 Polytetrafluoroethylene injectable, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90440
- Permanent ID
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.