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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 BAND
Classification Nameimplant, intragastric for morbid obesity
Generic Name gastric band
ApplicantALLERGAN, INC.
PMA NumberP000008
Supplement NumberS027
Date Received03/21/2012
Decision Date08/29/2013
Product Code
LTI[ Registered Establishments with LTI ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the packaging, sealing parameters and sterilization load size for the device.
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