§ 874.3495. Total ossicular replacement prosthesis.
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/us/cfr/t21/s§ 874.3495·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.
(b)Classification. Class II.