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 a software update (software version 3. 1. 3-c).
| 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 | 2020-09-04 |
| Decision Date | 2020-12-03 |
| PMA | P160013 |
| Supplement | S007 |
| 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 |