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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.
 
DeviceMaestro Rechargeable System
Generic Nameneuromodulator for obesity
ApplicantReShape Lifesciences, Inc.
2800 PATTON ROAD
SAINT PAUL, MN 55113
PMA NumberP130019
Supplement NumberS015
Date Received06/08/2017
Decision Date01/24/2018
Withdrawal Date 01/19/2021
Product Code PIM 
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 revised protocol for the post-approval study (PAS) protocol.
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