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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.
 
DeviceObalon Balloon System with Navigation Touch
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantReShape Lifesciences, Inc.
1001 Calle Amanecer
San Clemente, CA 92673
PMA NumberP160001
Supplement NumberS020
Date Received07/31/2018
Decision Date12/20/2018
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT03497910
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the use of the Obalon Navigation-Touch System for administration of the Obalon Balloon System.
Post-Approval StudyShow Report Schedule and Study Progress
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