PMA
P250025: TorEx Lung Perfusion System
FDA PMA · Normothermic preservation system for transplantation of initially unacceptable donor lungs · Traferox Technologies, Inc.
Key facts
| PMA number | P250025 |
|---|---|
| Trade name | TorEx Lung Perfusion System |
| Generic name | Normothermic preservation system for transplantation of initially unacceptable donor lungs |
| Applicant | Traferox Technologies, Inc. |
| Product code | PHO |
| Approval date | Jul 15, 2026 |
| Docket number | 26M-7880 |
| Notice date | Jul 15, 2026 |
At a glance
- None Supplements
- Jul 15, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: