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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
1 gorham island
westport, CT 06880
PMA NumberP080029
Date Received12/05/2008
Decision Date04/08/2010
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 10M-0220
Notice Date 04/23/2010
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002