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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 6 FRENCH SUTURE MEDIATED CLOSURE SYSTEM
Classification Namedevice, hemostasis, vascular
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS048
Date Received09/08/2003
Decision Date02/11/2004
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a name change, from perclose at mono-glide 6 french suture mediated closer (smc) system to perclose proglide 6 french suture mediated closer (smc) systems. The device, as modified, will be marketed under the trade name perclose proglide suture mediated closer (smc) systems and 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 5 to 8 fr. Sheaths. The perclose proglide 6 french suture mediated closer (smc) systems reduce the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic or interventional catheterization procedures without complicating clinical conditions.
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