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U.S. Department of Health and Human Services

Advisory Committees

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Gastroenterology And Urology Devices Panel – June 19, 2000

The Gastroenterology and Urology Devices Panel met on June 19, 2000 to discuss, make recommendations and vote on a premarket approval application for P00008 BioEnteric Corporation LAP-BAND Adjustable Gastric Banding System for the treatment of morbid obesity

This device is a silicone band placed during a laparoscopic or laparotomy procedure that encircles the stomach to create a small gastric pouch. The size of the pouch opening can be adjusted by addition or removal of fluid from the gastric band via an access port which is placed percutaneously. Saline can be added or removed depending on the desired weight loss.

The panel voted 6 to 4 for disapproval of the LAP-BAND based on a lack of adequate pre-market follow-up data for the 3-year period following implantation.

Contact: Mary J. Cornelius, Executive Secretary, (301) 594-2194, x118

Transcripts may be purchased from: (Written Request Only)

Miller Reporting Company
535 8th C. Street, S.E.
Washington, D.C. 20003
(202) 546-6666

-or-

Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax)