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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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 S013 S014 
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