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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.
 
DeviceMAESTRO RECHARGEABLE SYSTEM
Classification Nameneuromodulator for obesity
Generic Nameneuromodulator for obesity
Applicant
ENTEROMEDICS INC.
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 
S010 S011 S012 
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