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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.
 
DeviceXPS™ 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 NumberS014
Date Received06/18/2026
Decision Date09/16/2026
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 supplier and material change to the luer caps of the lung cannula set
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