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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
Classification Nameimplant, intragastric for morbid obesity
Generic Name gastric band
ApplicantALLERGAN, INC.
PMA NumberP000008
Supplement NumberS018
Date Received05/21/2010
Decision Date06/18/2010
Product Code
LTI[ Registered Establishments with LTI ]
Advisory Committee Gastroenterology/Urology
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the instructions for use to add ¿data from a post-approval study showed an estimated explant rate of 6. 5% per year over the first five years following implantation¿ to the adverse events section.
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