| 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 | CORDIS EXOSEAL VASCULAR CLOSURE DEVICE |
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| Generic Name | Device, hemostasis, vascular |
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| Applicant | Cordis US Corporation
14201 N.W. 60th Avenue
Miami Lakes, FL 33014 |
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| PMA Number | P100013 |
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| Date Received | 04/01/2010 |
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| Decision Date | 05/19/2011 |
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| Product Code |
MGB |
| Docket Number | 11M-0430 |
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| Notice Date | 06/03/2011 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT00345631
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE EXOSEAL VASCULAR CLOSURE DEVICE. THIS DEVICE IS INDICATED AS FOLLOWS: THE EXOSEAL VASCULAR CLOSURE DEVICE (VCD) IS INDICATED FOR FEMORAL ARTERY PUNCTURE SITE CLOSURE, REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING A STANDARD 5F, 6F, OR 7F VASCULAR SHEATH INTRODUCER WITH UP TO 12 CM WORKING LENGTH. ADDITIONALLY, THE EXOSEAL VCD IS INDICATED TO REDUCE TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE INTERVENTIONAL CATHETERIZATION PROCEDURES, USING A STANDARD 6F VASCULAR SHEATH INTRODUCER UP TO A 12 CM WORKING LENGTH, WHO HAVE RECEIVED PREPROCEDURAL AND/OR INTRAPROCEDURAL GLYCOPROTEIN (GP) 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 S009 S008 S007 S005 S014 S003 S012 S006 S004
S010 S013 S017 S020 S019 S021 S022 S023 S015 S018 S025 S024
S027 S026 S028 |
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