PMA
P250023: Allurion™ Gastric Balloon System
FDA PMA · IMPLANT, INTRAGASTRIC FOR MORBID OBESITY · Allurion Technologies, Inc.
Key facts
| PMA number | P250023 |
|---|---|
| Trade name | Allurion™ Gastric Balloon System |
| Generic name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
| Applicant | Allurion Technologies, Inc. |
| Owner/operator | Allurion Technologies, Inc. |
| Product code | LTI |
| Approval date | Feb 20, 2026 |
| Docket number | 26M-1920 |
| Notice date | Feb 23, 2026 |
| Establishment registration | 3011299930 |
| FEI number | 3011299930 |
At a glance
- 1–9 Supplements
- Sep 23, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: