PMA P180014S013

Device: XPS™ with Steen Solution™ Perfusate
Applicant: Xvivo Perfusion, Inc.
PMA number: P180014
Supplement: S013
Product code: PHO
Decision date: 2025-11-25
Classification: Gastroenterology, Urology
Generic name: Normothermic preservation system for transplantation of initially unacceptable donor lungs
Approval order statement: Approval for material changes to the organ chamber elbow fitting and the lung cannula set luer connector

Current openFDA PMA Record#

Device: XPS™ with Steen Solution™ Perfusate
Applicant: Xvivo Perfusion, Inc.
PMA number: P180014
Supplement: S013
Product code: PHO
Generic name: Normothermic preservation system for transplantation of initially unacceptable donor lungs
Decision date: 2025-11-25
Decision code: APPR
Date received: 2025-08-27
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for material changes to the organ chamber elbow fitting and the lung cannula set luer connector