| 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 | VASCADE VASCULAR CLOSURE SYSTEM |
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| Generic Name | Device, hemostasis, vascular |
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| Applicant | Cardiva Medical, Inc.
2900 Lakeside Dr., Suite 160
Santa Clara, CA 95054 |
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| PMA Number | P120016 |
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| Date Received | 08/03/2012 |
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| Decision Date | 01/31/2013 |
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| Product Code |
MGB |
| Docket Number | 13M-0592 |
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| Notice Date | 05/17/2013 |
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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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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
APPROVAL FOR THE VASCADE¿ VASCULAR CLOSURE SYSTEM (VCS). THIS DEVICE IS INDICATED FOR FEMORAL ARTERIAL ACCESS SITE CLOSURE WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVEUNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES USING A 5F, 6F, OR 7F PROCEDURAL SHEATH. THE VASCADE VCS IS ALSO INDICATED TO REDUCE TIME TO DISCHARGE ELIGIBILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR PROCEDURES USING A 5F, 6F, OR 7F PROCEDURAL SHEATH. |
| 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: |
S020 S023 S021 S022 S025 S030 S033 S024 S027 S036 S038
S006 S016 S017 S018 S009 S010 S011 S012 S013 S003 S007 S008
S014 S019 S015 S004 S005 S026 S039 S040 S028 S001 S002 S031
S029 S034 S035 S037 |
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