|Trade Name||VOYAGER RX CORONARY DILATATION 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 the voyager rx coronary dilatation catheter. The device, as modified, 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 occlusion for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction, and 3) balloon dilatation of stent after implantation (testing including the following guidant stents: multi-link: pixel and penta and zeta coronary stent systems).