Temporary circulatory support for up to 30 days for one or both sides of the heart to treat postcardiotomy patients who fail to wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient's heart will recover or whether the patient will need alternative, longer-term therapy
| Device | CentriMag Circulatory Support System |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | Abbott |
| Date Received | 2017-11-24 |
| Decision Date | 2019-12-06 |
| PMA | P170038 |
| Supplement | S |
| Product Code | DSQ |
| Advisory Committee | Cardiovascular |
| 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 |