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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 Avenue
Oxford OX4 4
PMA NumberP200035
Supplement NumberS009
Date Received06/09/2023
Decision Date09/06/2023
Product Code QQK 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a proposed change to the OrganOx metra Retained Unit. The approval is for replacement of the currently used Column Pair with a new Column Pair.
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