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Approval to: replace the brained suture with a monofilament polypropylene suture; combine the instructions for use of the perclose a-t monofilament 6 fr. suture mediated closure (smc) system and the chito-seal device into a single pamphlet. The device, as modified, will be marketed under the trade name perclose a-t monofilament 6 fr. suture mediated closure (smc) system and is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic and interventional catheterization procedures using 5 to 8 fr. sheaths. The perclose a-t monofilament 6 fr. smc system reduces the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic and interventional catheterization procedures without complicating clinical conditions.
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