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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 NameSTARCLOSE VASCULAR CLOSURE SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namevascular closure system
ApplicantABBOTT VASCULAR DEVICES
PMA NumberP050007
Date Received02/28/2005
Decision Date12/21/2005
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 06M-0016
Notice Date 01/13/2006
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 starclose vascular closure system. The device is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis, ambulation, and dischargeability in patients who have undergone diagnostic endovascular catheterization procedures utilizing a 5f or 6f procedural sheath.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 
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