DevicePMAs@therightstef:P860019_S150 JSONTXT 11 Projects

Approval for the SCIMED NC MAXXUM(TM) PTCA Catheter (20mm balloon length with balloon diameters of 2.0mm, 2.5-4.0mm in 1/4mm increments and 4.5mm, -5.0mm in 1/2mm increments; and 9mm and 15mm lengths with balloon diameterrs of 2.5-4.0mm in 1/4mm increments and 4.5mm - 5.0mm) in 1/2mm increments. The NC MAXXUM(TM) PTCA Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or byapss graft stenosis for th epurpose of improving myocardial perfusion. The NC MAXUUM(TM) PTCA Catheter (balloon models 2.5-4.0mm in diameter) is also indicated for the post-delivery expansion of balloon expandable stents.