TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 878 - GENERAL AND PLASTIC SURGERY DEVICES

subpart d - PROSTHETIC DEVICES

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]