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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.
 
DeviceORBERA INTRAGASTRIC BALLOON
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantBoston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP140008
Date Received04/29/2014
Decision Date08/05/2015
Product Code LTI 
Docket Number 15M-2964
Notice Date 08/06/2015
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT00730327
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ORBERA INTRAGASTRIC BALLOON. THE ORBERA INTRAGASTRIC BALLOON SYSTEM IS INDICATED FOR USE AS AN ADJUNCT TO WEIGHT REDUCTION FOR ADULTS WITH OBESITY WITH BODY MASS INDEX (BMI) OF >= 30 AND <= 40 KG/M2 AND IS TO BE USED IN CONJUNCTION WITH A LONG-TERM SUPERVISED DIET AND BEHAVIOR MODIFICATION PROGRAM DESIGNED TO INCREASE THE POSSIBILITY OF SIGNIFICANT LONG-TERM WEIGHT LOSS AND MAINTENANCE OF THAT WEIGHT LOSS. ORBERA IS INDICATED FOR ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT REDUCTION ALTERNATIVES, SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS. THE MAXIMUM PLACEMENT PERIOD FOR ORBERA IS 6 MONTHS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S005 S006 S007 S008 S011 S012 S013 S014 
S016 S017 S018 S019 S021 S022 S023 S024 S025 
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