- Device
- XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
- Applicant
- Xvivo Perfusion, Inc.
- PMA number
- P180014
- Supplement
- S004
- Product code
- PHO
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Decision date
- 2020-04-26
- Decision code
- APPR
- Date received
- 2020-01-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in the ventilator included in the XPS System to use the Hamilton C3 Ventilator.