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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 NumberS021
Date Received09/18/2020
Decision Date10/16/2020
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for implementation of a new retention force specification and corresponding quality control inspection.
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