§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(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.