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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 NumberS012
Date Received09/28/2023
Decision Date10/27/2023
Product Code QQK 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for an amendment to the OrganOx metra New Enrollment PAS (P200035/PAS003) protocol to include a study arm with the goal of collecting data on livers from DCD donors older than 40 years of age, perfused with the OrganOx metra and transplanted in adult recipients
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