|Trade Name||NC NINJA PTCA DILATATION CATHETER|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Generic Name||percutaneous transluminal angioplasty catheter|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the nc raptor ptca catheter (balloon diameters ranging from 2. 25 mm to 4. 0 mm and lengths ranging from 10 mm to 30 mm). The nc raptor ptca catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Models with the following balloon sizes (length x diameter) are also indicated for the post-delivery expansion of balloon expandable stents: 2. 25 mm x 10 mm to 15 mm; 3. 0 mm x 20 mm to 30 mm; and 4. 0 mm x 15 mm to 30 mm.