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.
Change to the dimensional tolerances of the cannula and modifications to the bonding process for two device subassemblies.
| Device | QUICK-CLOSE VASCULAR SUTURING SYSTEM |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | Cardiva Medical, Inc. |
| Date Received | 2014-11-26 |
| Decision Date | 2014-12-18 |
| PMA | P080029 |
| Supplement | S002 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |