PMA P180014S009

Device: XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate
Applicant: Xvivo Perfusion, Inc.
PMA number: P180014
Supplement: S009
Product code: PHO
Decision date: 2022-05-09
Generic name: Normothermic preservation system for transplantation of initially unacceptable donor lungs
Approval order statement: Approval for a XPS hardware update to replace obsoleted pump components with the manufacturers recommended new model components.

Current openFDA PMA Record#

Device: XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate
Applicant: Xvivo Perfusion, Inc.
PMA number: P180014
Supplement: S009
Product code: PHO
Generic name: Normothermic preservation system for transplantation of initially unacceptable donor lungs
Decision date: 2022-05-09
Decision code: APPR
Date received: 2022-02-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a XPS hardware update to replace obsoleted pump components with the manufacturers recommended new model components.