[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878.3610]

[Page 365-366]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 878--GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                      Subpart D--Prosthetic Devices
 
Sec. 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

[[Page 366]]

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]