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 | 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 Roadsuite 302andover, MA 01810 PMA NumberP200031 Supplement NumberS001 Date Received04/08/2022 Decision Date09/19/2022 Product Code QQK Advisory Committee Gastroenterology/Urology Clinical TrialsNCT02522871 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No |
| Date Received | 2022-04-08 |
| Decision Date | 2022-09-19 |
| PMA | P200031 |
| Supplement | S001 |
| Product Code | QQK |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TransMedics, Inc. 200 Minuteman Road suite 302 andover, MA 01810 PMA NumberP200031 Supplement NumberS001 Date Received04/08/2022 Decision Date09/19/2022 Product Code QQK Advisory Committee Gastroenterology/Urology Clinical TrialsNCT02522871 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No Combination ProductNo Approval Order Statement approval Of Revised Device Labeling To Reflect The Final Results Of The OCS Liver PROTECT Continuation Post-Approval Study |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200031 | Original Filing | |
| S001 | 2022-04-08 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| B00949381 | P200031 | 000 |
| B00944895 | P200031 | 000 |
| B00944905 | P200031 | 000 |
| B00944915 | P200031 | 000 |
| B00946643 | P200031 | 000 |
| B00946653 | P200031 | 000 |
| B00948895 | P200031 | 000 |
| B00950443 | P200031 | 000 |
| B00950491 | P200031 | 000 |
| B00944707 | P200031 | 000 |