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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 DRIVE
SANTA CLARA, CA 95054
PMA NumberP050007
Supplement NumberS002
Date Received02/09/2006
Decision Date01/16/2007
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES IN THE LABELING FOR THE DEVICE.
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