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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 & STARCLOSE SE VASCULAR CLOSURE SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantAbbott Vascular Devices
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP050007
Supplement NumberS006
Date Received05/07/2007
Decision Date07/30/2007
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 DESIGN CHANGES TO THE PUSHER BODY FOR BOTH THE STARCLOSE? VASCULAR CLOSURE SYSTEM (VCS) AND THE STARCLOSE? SE VASCULAR CLOSURE SYSTEM AD FOR THE ADDITION OF CHAMBERS ON THE INTERIOR OF THE STARCLOSE? SE VASCULAR CLOSURE SYSTEM TO IMPROVE THE RETRACTION OF THE THUMB ADVANCER.
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