21 C.F.R. § 878.3610 Esophageal prosthesis.
Title 21 - Food and Drugs
(a) Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal 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 17145, Mar. 31, 2000]
Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart D—Prosthetic Devices
§ 878.3610 Esophageal prosthesis.
