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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 St.
Englewood, CO 80110
PMA NumberP180014
Supplement NumberS008
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
Predetermined Change Control Plan AuthorizedNo
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.
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