PMA P180014S011

Device: XPS with Steen Solution Perfusate
Applicant: Xvivo Perfusion, Inc.
PMA number: P180014
Supplement: S011
Product code: PHO
Decision date: 2024-09-20
Classification: Gastroenterology, Urology
Generic name: Normothermic preservation system for transplantation of initially unacceptable donor lungs
Approval order statement: Approval for change from a leucocyte filter to an arterial filter, Medtronic Affinity™ AF100 Arterial Filter (K122760).

Current openFDA PMA Record#

Device: XPS with Steen Solution Perfusate
Applicant: Xvivo Perfusion, Inc.
PMA number: P180014
Supplement: S011
Product code: PHO
Generic name: Normothermic preservation system for transplantation of initially unacceptable donor lungs
Decision date: 2024-09-20
Decision code: APPR
Date received: 2024-06-20
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for change from a leucocyte filter to an arterial filter, Medtronic Affinity™ AF100 Arterial Filter (K122760).