[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878.3720]

[Page 397]
 
                        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. 878.3720  Tracheal prosthesis.

    (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]