PMA P250023
- Device
- Allurion™ Gastric Balloon System
- Applicant
- Allurion Technologies, Inc.
- PMA number
- P250023
- Product code
- LTI
- Decision date
- 2026-02-20
- Classification
- Gastroenterology, Urology
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- 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.
Current openFDA PMA Record#
- Device
- Allurion™ Gastric Balloon System
- Applicant
- Allurion Technologies, Inc.
- PMA number
- P250023
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2026-02-20
- Decision code
- APPR
- Date received
- 2025-06-30
- 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.