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 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 Received | 2022-06-07 |
| Decision Date | 2022-07-07 |
| PMA | P200035 |
| Supplement | S003 |
| 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 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. |
| 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 |