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U.S. Department of Health and Human Services

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAllurion™ Gastric Balloon System
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantAllurion Technologies, Inc.
11 Huron Dr.
Natick, MA 01760
PMA NumberP250023
Date Received06/30/2025
Decision Date02/20/2026
Product Code LTI 
Docket Number 26M-1920
Notice Date 02/23/2026
Advisory Committee Gastroenterology
Clinical TrialsNCT05368259
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Allurion Gastric Balloon System (AGBS) is indicated to promote short-term limited weight loss in adult individuals with obesity between the ages of 22 years and 65 years with a body mass index (BMI) greater than or equal to 30 kg/m2 and less than or equal to 40 kg/m2 who have had at least one unsuccessful attempt at a weight loss program. The residence time for each AGBS is variable with an average observed residence time of 15.3 weeks. The AGBS is to be used in conjunction with a moderate intensity lifestyle modification therapy program. The AGBS consists of up to two Allurion Balloons placed during a 10-month period.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 
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