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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameXVIVO Perfusion System (XPS) 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
Supplement NumberS008
Date Received05/31/2017
Decision Date08/14/2017
Product Code
PHO[ Registered Establishments with PHO ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for a new software version for the xps™ system, version 4. 0.
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