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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 NumberS002
Date Received02/27/2015
Decision Date07/24/2015
Product Code
PIM[ Registered Establishments with PIM ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL OF THE POST APPROVAL STUDY PROTOCOL.
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