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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 SYSTEM
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantReShape Lifesciences, Inc.
1001 Calle Amanecer
San Clemente, CA 92672
PMA NumberP000008
Supplement NumberS034
Date Received07/06/2015
Decision Date03/03/2016
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the following changes to the post-approval study for the device: revisions reflecting alignment of protocol terminology with terms used in the electronic datamanagement system and points of clarification based on IRB input.
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