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Approval for 1) a change in trade names for the Champion(TM) HP PTCA Catheters and Champion(TM) HP PTCA Catheters with Wrap(TM) Sheathing System previously approved under PMA supplements 5, 8, and 9, and 2) a reduction in the wall thickness of the 3.5 mm and 4.0 mm diameter balloons used in these designs. the devices, as modified, will be marketed under the trde names Champion(TM) NC PTCA Catheter and Wrap(TM) NC PTCA Catheter, and are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
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