[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: 21CFR874.3850]

[Page 352]
 
                        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 symptoms of vertigo 
and hearing loss due to endolymphatic hydrops (increase in endolymphatic 
fluid) of Meniere's disease.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document ``Class II Special Controls 
Guidance Document: Endolymphatic Shunt Tube With Valve; Guidance for 
Industry and FDA.''

[67 FR 20894, Apr. 29, 2002]