This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the ocs lung system, indicated for the preservation of standard criteria donor lungs in a near physiologic, ventilated, and perfused state for double lung transplantation.
| Device | Organ Care System (OCS™) Lung System |
| Classification Name | Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation |
| Generic Name | Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation |
| Applicant | TransMedics, Inc |
| Date Received | 2016-04-28 |
| Decision Date | 2018-03-22 |
| Notice Date | 2018-04-10 |
| PMA | P160013 |
| Supplement | S |
| Product Code | QBA |
| Docket Number | 18M-1237 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | TransMedics, Inc 200 Minuteman Road suite 302 andover, MA 01810 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |