Product code
PHO: Normothermic preservation system for transplantation of initially unacceptable donor lungs
FDA product code · Class III · Gastroenterology/Urology
Key facts
| Product code | PHO |
|---|---|
| Device | Normothermic preservation system for transplantation of initially unacceptable donor lungs |
| Device class | Class III |
| Review panel | Gastroenterology/Urology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | Yes |
| Definition | Preservation of donor lungs for transplantation. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- 1–9 HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database