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Approval for a modification of the closer s suture-mediated closure (smc) device to allow for a pre-tied knot upon device use. The device, as modified, will be marketed under the trade name closer ii 6fr. 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 6 fr. sheaths. The closer ii 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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