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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 SYSTEMS
Generic NameDevice, hemostasis, vascular
ApplicantAbbott Vascular Devices
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP050007
Supplement NumberS010
Date Received07/02/2008
Decision Date07/23/2008
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING ADDITIONS TO THE INSTRUCTIONS FOR USE.
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