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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
Classification Nameneuromodulator for obesity
Generic Nameneuromodulator for obesity
Applicant
ReShape Lifesciences, Inc.
2800 patton road
saint paul, MN 55113
PMA NumberP130019
Supplement NumberS013
Date Received03/02/2017
Decision Date03/22/2017
Product Code
PIM[ Registered Establishments with PIM ]
Advisory Committee Gastroenterology/Urology
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the incoming inspection, shelf storage, and preparation for shipment procedures for evaluating the battery of the Mobile Charger.
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