|Trade Name||SPRINTER OVER-THE-WIRE (OTW) BALLOON DILATATION CATHETER (MULTIPLE MODEL NUMBERS FOR THE 1.5 MM TO 4.0 MM DIAMETERS)|
|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 minor design, packaging and labeling changes to the stormer otw ballon dilatation catheter including the addition of 6 mm and 12 mm balloon lengths. The device, as modified, will be marketed under the trade name sprinter otw balloon dilatation catheter and is indicated as follows: for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The sprinter otw balloon dilatation catheter (balloon models 2. 5 mm - 4. 0 mm) is also indicated for post-delivery expansion of balloon expandable stents. Note: bench testing was conducted with the sprinter otw balloon dilatation catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to differences in stent design.