|Trade Name||PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSURE SYSTEM|
|Classification Name||device, hemostasis, vascular|
|Applicant||ABBOTT VASCULAR INC.|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling change - trade name|
|Expedited Review Granted?|| 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.