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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSTARCLOSE VASCULAR CLOSURE SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantAbbott Vascular Devices
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP050007
Supplement NumberS003
Date Received07/05/2006
Decision Date09/22/2006
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR: 1) INCREASING THE RADII OF THE DISTAL END OF THE SUPPORT TUBE (CLIP DELIVERY TUBE) FROM 0.002 INCHES TO 0.004 INCHES; 2) ADDING A 45 DEGREE CHAMFER TO THE PROXIMAL EDGE OF THE DISTAL RING; AND 3) REMOVING THE ?6F? NOTATION ON THE HANDLE OF THE DEVICE.
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