PMA
P240033: LungFX™ device
FDA PMA · Normothermic preservation system for transplantation of initially unacceptable donor lungs · Lung Bioengineering, Inc.
Key facts
| PMA number | P240033 |
|---|---|
| Trade name | LungFX™ device |
| Generic name | Normothermic preservation system for transplantation of initially unacceptable donor lungs |
| Applicant | Lung Bioengineering, Inc. |
| Product code | PHO |
| Approval date | Jun 22, 2026 |
At a glance
- None Supplements
- Jun 22, 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- No Withdrawn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: