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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.
 
DeviceORBERA Intragastric Balloon
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantBoston Scientific Corporation
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP140008
Supplement NumberS013
Date Received06/12/2018
Decision Date08/17/2018
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the ORBERA Intragastric Balloon System. The device 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.
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