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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 NumberS006
Date Received12/21/2022
Decision Date08/08/2023
Product Code QQK 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a manufacturing site located at Integrated Technologies Ltd, Viking House, Ellingham Way, Ashford, Kent, TN23 6NF, UK.
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