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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
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 NumberS007
Date Received11/23/2015
Decision Date02/03/2016
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 ProductNo
Approval Order Statement 
Approval for several software modifications (i. E. , software version 2. 2. 1 for the hamilton ventilator, software version 3. 4. 6 for the maquet cardiohelp, and software version 3. 3 for the xps¿ system).
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