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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 PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantABBOTT VASCULAR INC.
400 Saginaw Drive
Redwood City, CA 94063
PMA NumberP960043
Supplement NumberS080
Date Received07/20/2012
Decision Date04/15/2013
Product Code MGB 
Docket Number 13M-0464
Notice Date 05/07/2013
Advisory Committee Cardiovascular
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE PERCLOSE® PROGLIDE¿ SUTURE MEDIATED CLOSURE SYSTEM. THIS DEVICE IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTSWHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 21 F SHEATHS; FOR SHEATH SIZES GREATER THAN 8F, AT LEAST TWO DEVICES AND THE PRE-CLOSE TECHNIQUE AREREQUIRED.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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