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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameXPS WITH STEEN SOLUTION PERFUSATE
Classification Namenormothermic preservation system for transplantation of initially unacceptable donor lungs
Generic Namenormothermic preservation system for transplantation of initially unacceptable donor lungs
Applicant
XVIVO PERFUSION
3666 s inca street
englewood, CO 80110
HDE NumberH120003
Date Received07/10/2012
Decision Date08/12/2014
Product Code
PHO[ Registered Establishments with PHO ]
Docket Number 14M-1265
Notice Date 09/04/2014
Advisory Committee Gastroenterology
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for the xps¿ system with steen solution¿ perfusate. This device is indicated for the flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donorlungs during which time the ex-vivo function of the lungs can be reassessed for transplantation.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 
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