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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA 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
Supplement NumberS001
Date Received01/18/2006
Decision Date02/02/2007
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 07M-0058
Notice Date 02/21/2007
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications
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. This device is indicated as follows: the starclose vascular closure system is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis and ambulation, in patients who have undergone diagnostic or interventional endovascular catheterization procedures utilizing a 5f or 6f procedural sheath. The starclose vascular closure system is indicated for the percutaneous closure of common femoral artery access sites while reducing time to dischargeability in patients who have undergone diagnostic endovascular catheterization procedures utilizing a 5f or 6f procedural sheath.
Approval Order Approval Order
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