| 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 DRIVE
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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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: |
S004 S005 S017 S018 S015 S019 S022 S023 S006 S016 S009
S010 S011 S012 S013 S003 S007 S008 S001 S002 S014 S020 S021
S025 S027 S026 S030 S024 S028 S031 S029 S036 S033 S034 S035
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