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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.
 
DevicePERCLOSE A-T SUTURE MEDIATED CLOSURE(SMC) SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantAbbott Vascular, Inc.
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP960043
Supplement NumberS059
Date Received07/06/2006
Decision Date08/08/2006
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 CHANGES TO THE INSTRUCTIONS FOR USE (IFU) FOR THE PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM.
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