Section 878.3610 - Esophageal prosthesis(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