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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameneuromodulator for obesity
Generic Nameneuromodulator for obesity
2800 patton road
saint paul, MN 55113
PMA NumberP130019
Date Received06/21/2013
Decision Date01/14/2015
Product Code
PIM[ Registered Establishments with PIM ]
Docket Number 15M-0201
Notice Date 01/16/2015
Advisory Committee Gastroenterology/Urology
Clinical Trials NCT01327976
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the maestro® rechargeable system. This device is indicated for use in weight reduction in patients aged 18 years through adulthood who have a body mass index (bmi) of 40 to 45 kg/m2, or a bmi of 35 to 39. 9 kg/m2 with one or more obesity related co-morbid conditions, and have failed at least one supervised weight management program within the past five years.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009