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Business · 29/04/2002

FDA Reclassifies Endolymphatic Shunt Tube With Valve to Class II for Relief of Meniere's Disease Symptoms

The FDA is reclassifying the endolymphatic shunt tube with valve from class III to class II, allowing it to be marketed with special controls, in response to new information submitted by Hood Laboratories, to treat vertigo and hearing loss associated with Meniere's disease.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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