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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantReShape Lifesciences, Inc.
1001 Calle Amanecer
San Clemente, CA 92672
PMA NumberP000008
Supplement NumberS028
Date Received06/01/2012
Decision Date10/07/2014
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DESIGN CHANGES TO THE RAPIDPORT EZ ACCESS PORT, DESIGN CHANGES TO THE RAPIDPORT EZ ACCESS PORT APPLIER, AND PACKAGING CHANGES.
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