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.
| Device | OrganOx metra® System |
| Generic Name | Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation |
| Applicant | OrganOx Limitedoxford Science Park, Magdalen Centre, Robert Robinson Avenueoxford OX4 4 PMA NumberP200035 Supplement NumberS001 Date Received03/15/2022 Decision Date04/12/2022 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 Received | 2022-03-15 |
| Decision Date | 2022-04-12 |
| PMA | P200035 |
| Supplement | S001 |
| Product Code | QQK |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OrganOx Limited oxford Science Park, Magdalen Centre, Robert Robinson Avenue oxford OX4 4 PMA NumberP200035 Supplement NumberS001 Date Received03/15/2022 Decision Date04/12/2022 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 approval Of The Revised Protocol For The Post-approval Study (PAS) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P200035. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 05060462240043 | P200035 | 002 |
| 05060462240005 | P200035 | 002 |
| 05060462240029 | P200035 | 002 |