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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM
Classification Namedevice, hemostasis, vascular
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS080
Date Received07/30/2012
Decision Date04/15/2013
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 13M-0464
Notice Date 05/07/2013
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 patients who 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 are required.
Approval Order Approval Order
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