PMA P180014S014
- Device
- XPS™ with Steen Solution™ Perfusate
- Applicant
- Xvivo Perfusion, Inc.
- PMA number
- P180014
- Supplement
- S014
- Product code
- PHO
- Decision date
- 2026-09-16
- Classification
- Gastroenterology, Urology
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Approval order statement
- Approval for a supplier and material change to the luer caps of the lung cannula set
Current openFDA PMA Record#
- Device
- XPS™ with Steen Solution™ Perfusate
- Applicant
- Xvivo Perfusion, Inc.
- PMA number
- P180014
- Supplement
- S014
- Product code
- PHO
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Decision date
- 2026-09-16
- Decision code
- APPR
- Date received
- 2026-06-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a supplier and material change to the luer caps of the lung cannula set