PMA P180014S006
- Device
- XVIVO Perfusion System (XPS)™ with STEEN Solution™ Perfusate
- Applicant
- Xvivo Perfusion, Inc.
- PMA number
- P180014
- Supplement
- S006
- Product code
- PHO
- Decision date
- 2021-11-03
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- XVIVO Perfusion System (XPS)™ with STEEN Solution™ Perfusate
- Applicant
- Xvivo Perfusion, Inc.
- PMA number
- P180014
- Supplement
- S006
- Product code
- PHO
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Decision date
- 2021-11-03
- Decision code
- APPR
- Date received
- 2021-10-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.