Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: XVIVO Perfusion System with STEEN Solution Perfusate
• Generic Name: Normothermic preservation system for transplantation of initially unacceptable donor lungs
• Applicant: Xvivo Perfusion, Inc.; 3666 S Inca St.; Englewood, CO 80110
• PMA Number: P180014
• Supplement Number: S005
• Date Received: 09/23/2020
• Decision Date: 10/23/2020
• Product Code: PHO
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.