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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 NumberS004
Date Received01/27/2020
Decision Date04/26/2020
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 change in the ventilator included in the XPS System to use the Hamilton C3 Ventilator.
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