HDE supplement
H120003 S002: XPS WITH STEEN SOLUTION PERFUSATE
FDA HDE supplement · normal 75 day track · XVIVO PERFUSION
Key facts
| Original HDE | H120003 |
|---|---|
| Supplement number | S002 |
| Supplement type | normal 75 day track |
| 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 |
| Product code | PHO |
| Received date | Aug 28, 2014 |
| Decision date | Nov 10, 2014 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: