[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.3495]

[Page 351]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 874--EAR, NOSE, AND THROAT DEVICES--Table of Contents
 
                      Subpart D--Prosthetic Devices
 
Sec. 874.3495  Total ossicular replacement prosthesis.

    (a) Identification. A total ossicular replacement prosthesis is a 
device intended to be implanted for the total functional reconstruction 
of the ossicular chain and facilitates the conduction of sound waves 
from the tympanic membrance to the inner ear. The device is made of 
materials such as polytetrafluoroethylene, polytetrafluoroethylene with 
vitreous carbon fibers composite, porous polyethylene, or from a 
combination of these materials.
    (b) Classification. Class II.