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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceXPS™ 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
Date Received05/10/2018
Decision Date04/26/2019
Product Code PHO 
Docket Number 19M-2052
Notice Date 05/03/2019
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT01365429
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
Approval for the XPS™ with Steen Solution™ Perfusate. This device is indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex vivo function of the lungs can be reassessed for transplantation.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S003 S004 S005 S006 S007 S008 S009 S010 
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