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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 NumberS007
Date Received05/25/2017
Decision Date08/21/2017
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for revised protocol for the post-approval study (PAS) protocol.
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