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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 SE VASCULAR CLOSURE SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantABBOTT VASCULAR DEVICES
3200 LAKESIDE DRIVE
SANTA CLARA, CA 95054
PMA NumberP050007
Supplement NumberS004
Date Received10/24/2006
Decision Date03/23/2007
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DESIGN CHANGES T THE STARCLOSE VASCULAR CLOSURE SYSTEM (VCS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STARCLOSE SE VASCULAR CLOSURE SYSTEM AND 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 AND 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.
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