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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 NumberS014
Date Received04/28/2017
Decision Date05/24/2017
Withdrawal Date01/19/2021
Product Code PIM 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the inclusion of the Patient Transmit Coil in the Model 2504 Clinician Programmer Kit for the Maestro Rechargeable System.
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