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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 NumberS011
Date Received08/29/2023
Decision Date02/22/2024
Product Code QQK 
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT02775162
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) 180-day supplement, which requested approval for labeling modifications including the methdos and results of the OrganOx metra® WP01 Long-Term Follow-up PAS. This change is being made in response to the letter from FDA for P200035/R007 dated August 22, 2023. Based upon the information submitted, the PMA supplement is approved.
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