|
Device | OrganOx metra System |
Generic Name | Normothermic machine perfusion system for the preservation of donor livers prior to transplantation |
Applicant | OrganOx Limited Oxford Science Park, Magdalen Centre, Robert Robinson Avenue Oxford OX4 4 |
PMA Number | P200035 |
Supplement Number | S012 |
Date Received | 09/28/2023 |
Decision Date | 10/27/2023 |
Product Code |
QQK |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for an amendment to the OrganOx metra New Enrollment PAS (P200035/PAS003) protocol to include a study arm with the goal of collecting data on livers from DCD donors older than 40 years of age, perfused with the OrganOx metra and transplanted in adult recipients |