The organox metra system 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)
| Device | OrganOx metra System |
| Generic Name | Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation |
| Applicant | OrganOx Limited |
| Date Received | 2020-07-15 |
| Decision Date | 2021-12-09 |
| PMA | P200035 |
| Supplement | S |
| Product Code | QQK |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OrganOx Limited oxford Science Park, Magdalen Centre, Robert Robinson Avenue oxford OX4 4 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P200035 | | Original 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