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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceXVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate
Generic NameNormothermic preservation system for transplantation of initially unacceptable donor lungs
ApplicantXVIVO Perfusion, Inc.
3666 S. Inca Street
Englewood, CO 80110
PMA NumberP180014
Supplement NumberS009
Date Received02/08/2022
Decision Date05/09/2022
Product Code PHO 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for a XPS hardware update to replace obsoleted pump components with the manufacturers recommended new model components.
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