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52 FR 33702, Sept. 4, 1987, unless otherwise noted.
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Nomenclature changes to part 888 appear at 73 FR 35341, June 23, 2008.
(a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a polyester reinforced medical grade silicone elastomer intended for use in the surgical reconstruction of a flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for the ligament or tendon nor to function as a scaffold for soft tissue ingrowth.
(b) Classification. Class II.