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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 NameXPS with STEEN Solution PErfusate (HDE #H120003)
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 st.
englewood, CO 80110
HDE NumberH120003
Supplement NumberS009
Date Received11/13/2018
Decision Date12/12/2018
Product Code
PHO[ Registered Establishments with PHO ]
Advisory Committee Gastroenterology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Change in the synergy health/steris ast sterilization site for the xvivo pgm disposable sensors from denver, co to petaluma, california.
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