|Trade Name||DURA STAR RX PTCA BALLOON DILATATION CATHETER|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Generic Name||catheters, transluminal coronary angioplasty, percutaneous|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new catheter model. The device, as modified, will be marketed under the trade name dura star rx ptca balloon dilatation catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. In addition, the dura star rx ptca dilatation catheter is indicated for post-delivery expansion of balloon expandable stents.