(VNS) Warning letter from the FDA

[Guest guest]

Department of Health and Human Services Public Health Service

Food and Drug Administration

Dallas District

4040 North Central Expressway

Dallas, Texas 75204-3145

December 22, 2004

Ref: 2005-DAL-WL-7

WARNING LETTER

CERTIFIED MAIL

RETURNED RECEIPT REQUESTED

Mr. (Skip) P. Cummins, President and CEO

Cyberonics, Inc.

100 Cyberonics Blvd.

Houston, Texas 77058 - 2017

Dear Mr. Cummins:

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).

http://www.fda.gov/foi/warning_letters/g5129d.htm