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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 NameQUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantSUB-Q, INC.
PMA NumberP010049
Date Received09/10/2001
Decision Date03/25/2002
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 02M-0134
Notice Date 03/29/2002
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 quickseal femoral arterial closure system. The device is indicated for the delivery of gelfoam for the extravascular closure of the femoral artery access site. The system is indicated for use in reducing time to hemostasis at femoral artery puncture sites and in reducing time to ambulation in patients who have undergone diagnostic or interventional procedures using 8 french or smaller procedural sheaths. The device reduces time to eligibility for hospital discharge in patients who have undergone diagnostic or interventional procedures and reduces time to actual hospital discharge in patients who have undergone diagnostic procedures.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S011 S012 
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