PMA supplement
P180014 S013: XPS™ with Steen Solution™ Perfusate
FDA PMA supplement · Real-Time Process · Xvivo Perfusion, Inc.
Key facts
| Original PMA | P180014 |
|---|---|
| Supplement number | S013 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | XPS™ with Steen Solution™ Perfusate |
| Generic name | Normothermic preservation system for transplantation of initially unacceptable donor lungs |
| Applicant | Xvivo Perfusion, Inc. |
| Product code | PHO |
| Received date | Aug 27, 2025 |
| Decision date | Nov 25, 2025 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: