HDE
H120003: XPS WITH STEEN SOLUTION PERFUSATE
FDA Humanitarian Device Exemption · XVIVO PERFUSION
Key facts
| HDE number | H120003 |
|---|---|
| Trade name | XPS WITH STEEN SOLUTION PERFUSATE |
| Generic name | Normothermic preservation system for transplantation of initially unacceptable donor lungs |
| Applicant | XVIVO PERFUSION |
| Owner/operator | XVIVO Perfusion AB |
| Product code | PHO |
| Approval date | Aug 12, 2014 |
| Docket number | 14M-1265 |
| Notice date | Sep 4, 2014 |
| Establishment registration | 3028907862 |
| FEI number | 3028907862 |
At a glance
- 10–99 Supplements
- Dec 12, 2018 Latest supplement decision
- Yes Summary of safety and probable benefit 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 HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: