|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Generic Name||coronary balloon dilatation catheter|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the acs tx2000(tm) coronary dilatation catheter with new balloon lengths (15 mm and 40 mm), additional balloon diameters for the 20 mm and 30 mm balloon lengths, and revised labeling.