- Device
- XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate
- Applicant
- Xvivo Perfusion, Inc.
- PMA number
- P180014
- Supplement
- S007
- Product code
- PHO
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Decision date
- 2022-07-14
- Decision code
- APPR
- Date received
- 2021-12-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at IPAX Inc. as the new contract manufacturer for manufacturing the XVIVO Perfusion System.