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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 NameBIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
Classification Nameimplant, intragastric for morbid obesity
Generic Nameadjustable gastric banding system
ApplicantBIOENTERICS CORP.
PMA NumberP000008
Supplement NumberS002
Date Received01/24/2002
Decision Date08/01/2002
Product Code
LTI[ Registered Establishments with LTI ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following modifications to the lap-band adustable gastric banding (lagb) system: 1) introduction of a redesigned access port (access port ii); 2) replace the calibration tube (calibration tube i) currently provided in the lagb) system with a redesigned calibration tube (calibration tube ii); and 3) introduction of 2" access port needles to be sold as an accessory item. In addition to being sold as components of the lagb system, both the access port ii and the calibration tube ii will be sold as separate accessories.
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