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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 NumberS036
Date Received03/13/2026
Decision Date04/10/2026
Product Code QQK 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
including additional bioburden and bacterial endotoxin testing for the oxygenator component of the D0146/D0146-US Disposable Set
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