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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 Rd.
Roseville, MN 55113
PMA NumberP130019
Supplement NumberS010
Date Received08/26/2016
Decision Date09/20/2016
Withdrawal Date01/19/2021
Product Code PIM 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Material change for the flux used during in-process rework, updated inspection steps, and clarified process instructions for the Model 2002 Rechargeable Neuroregulator.
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