|Trade Name||USCI APOLLO RELY OVER-THE-WIRE BALLON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE|
|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 ptca catheter line. The device, as modified, will be marketed under the trade name usci* apollo* rely over-the-wire balloon dilatation catheter with hydro/pel* coating and miniquet* device 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.