PMA P180014S008

Device: XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
Applicant: Xvivo Perfusion, Inc.
PMA number: P180014
Supplement: S008
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 software upgrade in the XPS (software v5.3.0) to address minor bug fixes and to remove the software control of XPS’ auxiliary pumps.

Current openFDA PMA Record#

Device: XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
Applicant: Xvivo Perfusion, Inc.
PMA number: P180014
Supplement: S008
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 software upgrade in the XPS (software v5.3.0) to address minor bug fixes and to remove the software control of XPS’ auxiliary pumps.