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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 NumberS029
Date Received09/13/2012
Decision Date11/09/2012
Product Code
LTI[ Registered Establishments with LTI ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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