| Note: 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. |
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| Device | QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM) |
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| Generic Name | Device, hemostasis, vascular |
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| Applicant | Cardiva Medical, Inc.
2900 Lakeside Drive
Suite 160
Santa Clara, CA 95054 |
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| PMA Number | P080029 |
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| Date Received | 12/05/2008 |
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| Decision Date | 04/08/2010 |
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| Product Code |
MGB |
| Docket Number | 10M-0220 |
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| Notice Date | 04/23/2010 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 |
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