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.
The installation of additional data loggers for process monitoring at a manufacturing site
| Device | CentriMag Circulatory Support System |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | Abbott |
| Date Received | 2020-04-01 |
| Decision Date | 2020-04-16 |
| PMA | P170038 |
| Supplement | S003 |
| Product Code | DSQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott 6035 Stoneridge Drive pleasanton, CA 94588 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170038 | Original Filing | |
| S010 | 2022-04-13 | 30-day Notice |
| S009 | 2022-03-15 | 30-day Notice |
| S008 | 2021-08-24 | 135 Review Track For 30-day Notice |
| S007 | 2021-08-02 | Normal 180 Day Track No User Fee |
| S006 | 2021-07-08 | 30-day Notice |
| S005 | 2020-07-31 | Normal 180 Day Track No User Fee |
| S004 | ||
| S003 | 2020-04-01 | 30-day Notice |
| S002 | ||
| S001 | 2020-01-08 | Normal 180 Day Track No User Fee |