Company:Cyberonics Inc.
Product: Vagus Nerve Stimulator
Date: 12/22/04

During an inspection of your firm’s manufacturing operations located in Houston, Texas, on July 12 through September 15, 2004, United States Food and Drug Administration (FDA) Investigator, Ellen J. Tave, determined that your firm manufactures the Vagus Nerve Stimulator (VNS), an implanted generator that is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with medically intractable partial seizures. The VNS system includes a pulse generator, programming wand, programming software. electrode leads, tunneling tool, and accessory pack. This product is a device as defined in Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

FDA District: Dallas District Office