- Device
- XPS™ with Steen Solution™ Perfusate
- Applicant
- Xvivo Perfusion, Inc.
- PMA number
- P180014
- Supplement
- S012
- Product code
- PHO
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Decision date
- 2025-05-08
- Decision code
- APPR
- Date received
- 2024-08-07
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the sterilization procedure for the perfusate gas monitor (PGM) sensors of the XPS™ System.