OrganOx metra System

FDA Premarket Approval P200035 S003

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.

Pre-market Approval Supplement Details

DeviceOrganOx metra System
Generic NameNormothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
ApplicantOrganOx Limitedoxford Science Park, Magdalen Centre, Robert Robinson Avenueoxford OX4 4 PMA NumberP200035 Supplement NumberS003 Date Received06/07/2022 Decision Date07/07/2022 Product Code QQK  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Date Received2022-06-07
Decision Date2022-07-07
PMAP200035
SupplementS003
Product CodeQQK 
Advisory CommitteeGastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductNo
Applicant AddressOrganOx Limited
oxford Science Park, Magdalen Centre, Robert Robinson Avenue
oxford OX4 4 PMA NumberP200035 Supplement NumberS003 Date Received06/07/2022 Decision Date07/07/2022 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 Approval Order Statement  
PMA Was Approved December 9, 2021 With The Following Conditions Of Approval:In Addition To The Annual Report Requirements, You Must Provide The Following Data In Post-approval Study (PAS) Reports For Each Of Three PAS.

Supplemental Filings

Supplement NumberDateSupplement Type
P200035Original Filing
S003 2022-06-07 Normal 180 Day Track No User Fee
S002 2022-03-21 Normal 180 Day Track No User Fee
S001 2022-03-15 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
05060462240043 P200035 002
05060462240005 P200035 002

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