PMA P250023
- Device
- Allurion™ Gastric Balloon System
- Applicant
- Allurion Technologies, Inc.
- PMA number
- P250023
- Supplement
- S002
- Product code
- LTI
- Decision date
- 2026-09-23
- Classification
- Gastroenterology, Urology
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- the revised protocol for the post-approval study (PAS) Allurion Gastric Balloon PAS
Current openFDA PMA Record#
- Device
- Allurion™ Gastric Balloon System
- Applicant
- Allurion Technologies, Inc.
- PMA number
- P250023
- Supplement
- S002
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2026-09-23
- Decision code
- APPR
- Date received
- 2026-08-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- the revised protocol for the post-approval study (PAS) Allurion Gastric Balloon PAS