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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 IFU
Generic NameDevice, hemostasis, vascular
ApplicantABBOTT VASCULAR DEVICES
3200 LAKESIDE DRIVE
SANTA CLARA, CA 95054
PMA NumberP050007
Supplement NumberS028
Date Received02/22/2011
Decision Date03/24/2011
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO ADD ADJUNCTIVE COMPRESSION LANGUAGE TO THE LABELING AND INSTRUCTIONS FOR USE.
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