|Trade Name||SPRINTER MX2 BALLOON DILATATION CATHETER|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Generic Name||ptca catheter|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for adding a new catheter to the approved product line. The device, as modified, will be marketed under the trade name sprinter mx2 and is indicated for balloon dilatation for the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter (balloon models 2. 5 mm ? 4. 0 mm) is also indicated for the post-delivery expansion of balloon expandable stents. Note: bench testing was conducted with the sprinter balloon dilatation catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers? stents due to differences i stent design.