|
Device | Organ Care System (OCS™) Liver |
Generic Name | Normothermic machine perfusion system for the preservation of donor livers prior to transplantation |
Applicant | TransMedics, Inc. 200 Minuteman Road Suite 302 Andover, MA 01810 |
PMA Number | P200031 |
Date Received | 06/30/2020 |
Decision Date | 09/28/2021 |
Product Code |
QQK |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT02522871
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for Organ Care System (OCS) Liver for the indication of: The TransMedics® Organ Care System (OCS) Liver is a portable extracorporeal liver perfusion and monitoring system indicated for preservation and monitoring of hemodynamics and metabolic function which allows for ex-vivo assessment of liver allografts from donors after brain death (DBD) or liver allografts from donors after circulatory death (DCD) <=55 years old and with <=30 mins of warm ischemic time, macrosteatosis <=15%, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S006 |