|
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 | S010 |
Date Received | 06/30/2023 |
Decision Date | 08/09/2023 |
Product Code |
QQK |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for replacing OrganOx metra Liver Perfusion Circuit (Part Number D0146) IVC cannula component model RV40028 with model V122-28. |