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 ergonomic changes to the quick-close vascular suturing system.
| Device | QUICK-CLOSE VASCULAR SUTURING SYSTEM |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | Cardiva Medical, Inc. |
| Date Received | 2010-08-18 |
| Decision Date | 2011-03-11 |
| PMA | P080029 |
| Supplement | S001 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cardiva Medical, Inc. 2900 Lakeside Drive suite 160 santa Clara, CA 95054 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P080029 | Original Filing | |
| S002 | 2014-11-26 | 30-day Notice |
| S001 | 2010-08-18 | Normal 180 Day Track |