[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: 21CFR874.3850]

[Page 344]
 
                        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. 874.3850  Endolymphatic shunt tube with valve.

    (a) Identification. An endolymphatic shunt tube with valve is a 
device that consists of a pressure-limiting valve associated with a tube 
intended to be implanted in the inner ear to relieve the symptoms of 
vertigo. The device directs excess endolymph from the distended end of 
the endolymphatic system into the mastoid cavity where resorption 
occurs. The function of the pressure-limiting inner ear valve is to 
impede the flow of endolymph so that a physiologically normal 
endolymphatic pressure is maintained. The device is made of silicone 
elastomer and polyamide and contains gold radiopaque markers within the 
silicone elastomer sheath.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 874.3.