|
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 | S005 |
Date Received | 12/07/2022 |
Decision Date | 02/14/2023 |
Product Code |
QQK |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of a Quick Reference Guide (QRG) as a supplement to existing labeling for the OrganOx metra System. |