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| Device | Allurion™ Gastric Balloon System |
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| Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
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| Applicant | Allurion Technologies, Inc.
11 Huron Dr.
Natick, MA 01760 |
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| PMA Number | P250023 |
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| Date Received | 06/30/2025 |
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| Decision Date | 02/20/2026 |
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| Product Code |
LTI |
| Docket Number | 26M-1920 |
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| Notice Date | 02/23/2026 |
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| Advisory Committee |
Gastroenterology/Urology |
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| Clinical Trials | NCT05368259
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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 Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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