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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 NumberS012
Date Received08/07/2024
Decision Date05/08/2025
Product Code PHO 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the sterilization procedure for the perfusate gas monitor (PGM) sensors of the XPS™ System.
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