|Trade Name||PROCROSS RELY SP PTCA CATHETER|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Generic Name||catheters, transluminal coronary angioplasty, percutaneous|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of ten models to your currently marketed line of usci(r) procross(tm) over-the-wire balloon dilatation catheters with hydro/pel(r) coating. The device, as modified, will be marketed under the trade name usci(r) procross(tm) sp over-the-wire balloon dilatation catheters with hydro/pel(r) coating 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.