This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the quick-close vascular suturing system. This device is indicated as follows:the quick-close vascular suturing system is indicated to close femoral artery accesssites and to reduce time-to-hemostasis and time-to-ambulation in patients who haveundergone diagnostic or interventional endovascular procedures utilizing a 5, 6, 7, or 8french procedural sheath. Additionally, the quick-close vascular suturing system is indicated to reduce time-to-hemostasis in patients who have undergone interventionalendovascular procedures utilizing a 5, 6, 7, or 8 french procedural sheath, who havereceived intraprocedural glycoprotein iib/iiia inhibitor therapy.
| Device | QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM) |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | Cardiva Medical, Inc. |
| Date Received | 2008-12-05 |
| Decision Date | 2010-04-08 |
| Notice Date | 2010-04-23 |
| PMA | P080029 |
| Supplement | S |
| Product Code | MGB |
| Docket Number | 10M-0220 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cardiva Medical, Inc. 2900 Lakeside Drive suite 160 santa Clara, CA 95054 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P080029 | Original Filing | |
| S002 | 2014-11-26 | 30-day Notice |
| S001 | 2010-08-18 | Normal 180 Day Track |