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 protocol for post-approval study (pas) protocol.
| 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 | 2018-04-06 |
| Decision Date | 2018-06-14 |
| PMA | P160013 |
| Supplement | S001 |
| Product Code | QBA |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| 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 |