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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.
 
DeviceAllurion™ Gastric Balloon System
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantAllurion Technologies, Inc.
11 Huron Dr.
Natick, MA 01760
PMA NumberP250023
Supplement NumberS002
Date Received08/24/2026
Decision Date09/23/2026
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT05368259
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  
the revised protocol for the post-approval study (PAS) Allurion Gastric Balloon PAS
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