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
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