[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: 21CFR874.3820]

[Page 369]
 
                        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. 874.3820  Endolymphatic shunt.

    (a) Identification. An endolymphatic shunt is a device that consists 
of a tube or sheet intended to be implanted to relieve the symptons of 
vertigo. The device permits the unrestricted flow of excess endolymph 
from the distended end of the endolymphatic system into the mastoid 
cavity where resorption occurs. This device is made of 
polytetrafluoroethylene or silicone elastomer.
    (b) Classification. Class II.