PMA
P180014: XPS™ with Steen Solution™ Perfusate
FDA PMA · Normothermic preservation system for transplantation of initially unacceptable donor lungs · Xvivo Perfusion, Inc.
Key facts
| PMA number | P180014 |
|---|---|
| Trade name | XPS™ with Steen Solution™ Perfusate |
| Generic name | Normothermic preservation system for transplantation of initially unacceptable donor lungs |
| Applicant | Xvivo Perfusion, Inc. |
| Owner/operator | XVIVO Perfusion AB |
| Product code | PHO |
| Approval date | Apr 26, 2019 |
| Docket number | 19M-2052 |
| Notice date | May 3, 2019 |
| Establishment registration | 3007710603 |
| FEI number | 3007710603 |
At a glance
- 10–99 Supplements
- Sep 16, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: