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.
Approval for an alternate check valve for the ocs™ lung system.
| Device | Organ Care System (OCS™) Lung System |
| Generic Name | Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation |
| Applicant | TransMedics, Inc |
| Date Received | 2021-05-04 |
| Decision Date | 2021-08-02 |
| PMA | P160013 |
| Supplement | S008 |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TransMedics, Inc 200 Minuteman Road suite 302 andover, MA 01810 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160013 | Original Filing | |
| S009 | 2022-02-07 | Real-time Process |
| S008 | 2021-05-04 | Real-time Process |
| S007 | 2020-09-04 | Real-time Process |
| S006 | 2019-09-23 | Real-time Process |
| S005 | 2019-09-23 | Real-time Process |
| S004 | ||
| S003 | 2018-09-27 | Real-time Process |
| S002 | ||
| S001 | 2018-04-06 | Normal 180 Day Track No User Fee |