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51 FR 40389, Nov. 6, 1986, unless otherwise noted.
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Subscribe to: 21 CFR 874.3450
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Nomenclature changes to part 874 appear at 73 FR 35341, June 23, 2008.
(a) Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.
(b) Classification. Class II.