|Trade Name||USCI APOLLO RELY ADDITIONAL SIZES|
|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 three balloon sizes to the usci(r) apollo(tm) rely(r) over-the-wire balloon dilatation catheter with hydro/pel(r) coating and miniquet device catheter line. The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.