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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOrganOx metra® System
Generic NameNormothermic machine perfusion system for the preservation of donor livers prior to transplantation
ApplicantOrganox Limited
Oxford Science Park, Magdalen Centre, Robert Robinson Ave.
Oxford OX4 4GA
PMA NumberP200035
Supplement NumberS007
Date Received02/17/2023
Decision Date11/20/2023
Product Code QQK 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
This 180-day PMA supplement requested approval for changes to the hardware and software of the OrganOx metra Retained Unit (Part Number D0003). These changes include the update of hardware components due to obsolescence and to facilitate electrical safety and electromagnetic compatibility (EMC) testing compliance. In addition, the software Operating System (OS) is updated from Windows 7 to Windows 10 and the Graphical User Interface (GUI) component of the system software is updated to accommodate the update to Windows 10 operating system.
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