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 of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p170038.
| Device | CentriMag Circulatory Support System |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | Abbott |
| Date Received | 2021-08-02 |
| Decision Date | 2021-08-19 |
| PMA | P170038 |
| Supplement | S007 |
| Product Code | DSQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| 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 |