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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 SYSTEM
Classification Nameimplant, intragastric for morbid obesity
Generic Name gastric band
ApplicantBIOENTERICS CORP.
PMA NumberP000008
Supplement NumberS003
Date Received03/13/2002
Decision Date05/24/2002
Product Code
LTI[ Registered Establishments with LTI ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at mcghan medico, barreal de heredia, costa rica.
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