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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 (LAGB) SYSTEM
Classification Nameimplant, intragastric for morbid obesity
Generic Name gastric band
ApplicantALLERGAN, INC.
PMA NumberP000008
Supplement NumberS014
Date Received12/18/2008
Decision Date01/16/2009
Product Code
LTI[ Registered Establishments with LTI ]
Advisory Committee Gastroenterology/Urology
Supplement Type Special Supplement
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifying the labeling to identify the ¿pars flaccida¿ technique as the recommended technique to use during surgical placement of the device.
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