HDE supplement
H120003 S009: XPS with STEEN Solution PErfusate (HDE #H120003)
FDA HDE supplement · 30-day notice · XVIVO PERFUSION
Key facts
| Original HDE | H120003 |
|---|---|
| Supplement number | S009 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | XPS with STEEN Solution PErfusate (HDE #H120003) |
| Generic name | Normothermic preservation system for transplantation of initially unacceptable donor lungs |
| Applicant | XVIVO PERFUSION |
| Product code | PHO |
| Received date | Nov 13, 2018 |
| Decision date | Dec 12, 2018 |
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: