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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 |
Date Received | 07/15/2020 |
Decision Date | 12/09/2021 |
Product Code |
QQK |
Docket Number | 21M-1317 |
Notice Date | 12/17/2021 |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT02775162
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the OrganOx metra System. The device is approved for the following indication: The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) <=40 years old, with <=20 mins of functional warm ischemic time (time from donor systolic blood pressure <50 mmHg), and macrosteatosis <=15%, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 |