[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.3450]

[Page 343]
 
                        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. 874.3450  Partial ossicular replacement prosthesis.

    (a) Identification. A partial ossicular replacement prosthesis is a 
device intended to be implanted for the functional reconstruction of 
segments of the ossicular chain and facilitates the conduction of sound 
wave from the tympanic membrane to the inner ear. The device is made of 
materials such as stainless steel, tantalum, polytetrafluoroethylene, 
polyethylene, polytetrafluoroethylene with carbon fibers composite, 
absorbable gelatin material, porous polyethylene, or from a combination 
of these materials.
    (b) Classification. Class II.