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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.
 
Trade NameQUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM)
Classification Namedevice, hemostasis, vascular
ApplicantINTERVENTIONAL THERAPIES, LLC.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 access sites and to reduce time-to-hemostasis and time-to-ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5, 6, 7, or 8 french procedural sheath. Additionally, the quick-close vascular suturing system is indicated to reduce time-to-hemostasis in patients who have undergone interventional endovascular procedures utilizing a 5, 6, 7, or 8 french procedural sheath, who have received intraprocedural glycoprotein iib/iiia inhibitor therapy.
Approval Order Approval Order
Supplements: S001 S002 
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