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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 NumberS007
Date Received01/20/2016
Decision Date02/12/2016
Product Code
PIM[ Registered Establishments with PIM ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Material change for the flux used during in-process rework, the use of a 10 zone Vitronics reflow oven, machine placement of the RF shield component, clarifying process instructions, and use of the alternate Mydata assembly line for the Model 2402 Mobile Charger.
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