21 C.F.R. § 874.3850 Endolymphatic shunt tube with valve.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart D—Prosthetic Devices
§ 874.3850 Endolymphatic shunt tube with valve.
