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)
| Device | Organ Care System (OCS™) Liver |
| Generic Name | Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation |
| Applicant | TransMedics, Inc. |
| Date Received | 2020-06-30 |
| Decision Date | 2021-09-28 |
| PMA | P200031 |
| Supplement | S |
| Product Code | QQK |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TransMedics, Inc. 200 Minuteman Road suite 302 andover, MA 01810 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P200031 | | Original Filing |
| S001 |
2022-04-08 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices