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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 NumberS004
Date Received06/17/2022
Decision Date08/22/2024
Product Code QQK 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
response to the additional information in the Not Approvable letter sent from FDA on January 18, 2024 for the cleaning validation of the MLA using quantitative test methods.
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