|Trade Name||NC STORMER MX2/OTW BALLOON DILATATION 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 addition of the nc stormer mx2 catheter with two additional lengths (as a modified version of the approved nc stormer mx catheter) and the addition of two additional lengths for the nc stormer otw catheter.