21 CFR 878.3500 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — General And Plastic Surgery Devices (§ 878.1 To § 878.5910) — Prosthetic Devices (§ 878.3250 To § 878.3925) — Polytetrafluoroethylene with carbon fibers composite implant material.

4 Aug 2016

(a) Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

(b) Classification. Class II.

21 CFR 878.3500