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) Lung System |
| Generic Name | Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation |
| Applicant | TransMedics, Inc200 Minuteman Roadsuite 302andover, MA 01810 PMA NumberP160013 Supplement NumberS009 Date Received02/07/2022 Decision Date05/06/2022 Product Codes PHO QBA Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-02-07 |
| Decision Date | 2022-05-06 |
| PMA | P160013 |
| Supplement | S009 |
| 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 PMA NumberP160013 Supplement NumberS009 Date Received02/07/2022 Decision Date05/06/2022 Product Codes PHO QBA Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For The Addition Of The Lung Small Trachea Cannula Set To The Currently Available Trachea Cannulas For The OCS Lung System. |
| 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 |