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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 System
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantBoston Scientific Corporation
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP140008
Supplement NumberS006
Date Received05/08/2017
Decision Date06/06/2017
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for labeling changes have been requested by the Office of Surveillance and Biometrics, Signal Management Program as a result of a safety signal with fluid filled gastric balloons.
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