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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Cordis Corporation
6500 paseo padre parkway
fremont, CA 94555
PMA NumberP100013
Date Received04/01/2010
Decision Date05/19/2011
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 11M-0430
Notice Date 06/03/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00345631
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S012 S013