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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 NumberS020
Date Received09/16/2010
Decision Date10/08/2010
Product Code
LTI[ Registered Establishments with LTI ]
Advisory Committee Gastroenterology/Urology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the directions for use to add cautionary statements regarding how the needle is to be inserted into the access port septum to prevent damage to the access port.
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