|Trade Name||VOYAGER OTW CORONARY DILATION CATHETER|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Generic Name||percutaneous transluminal coronary angioplasty balloon dilatation catheter|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new coronary dilatation catheter. The device, as modified, will be marketed under the trade name voyager otw coronary dilatation catheter and is indicated for 1) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction, 3) balloon dilatation of a stent after implantation.