§ 878.3720. Tracheal prosthesis.
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/us/cfr/t21/s§ 878.3720·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.
(b)Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.” [65 FR 17146, Mar. 31, 2000]