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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 NumberS012
Date Received12/08/2016
Decision Date12/22/2016
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 to updated the Clinician Programmer (CP) build verification procedure to include a specific instructional step to ensure that the internet upload capability feature has been disabled.
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