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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 NumberS008
Date Received03/20/2023
Decision Date04/18/2023
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 the OrganOx metra®. The New Enrollment PAS is a multi-center, single-arm, unblinded post-approval study designed to compare recipients of PAS NMP livers versus IDE SCS livers with respect to adverse biliary-related events. Recruitment will take place at a minimum of 10 sites which are UNOS member liver transplant centers.
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