(a)Identification. A glenoid fossa prosthesis is a device that is intended to be implanted in the temporomandibular joint to augment a glenoid fossa or to provide an articulation surface for the head of a mandibular condyle.
(b)Classification. Class III.
(c)Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 30, 1999, for any glenoid fossa prosthesis that was in commercial distribution before May 28, 1976, or that has on or before March 30, 1999, been found to be substantially equivalent to a glenoid fossa prosthesis that was in commercial distribution before May 28, 1976. Any other glenoid fossa prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
[59 FR 65478, Dec. 20, 1994, as amended at 63 FR 71746, Dec. 30, 1998]
Title 21 published on 2014-04-01.
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