|Trade Name||VITESSE POINT 9 MM X80 & EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODELS 110-004 AND 110-002|
|Classification Name||device, angioplasty, laser, coronary|
|Generic Name||coronary angioplasty catheter|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - specifications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Vitesse point 9mm x80 percutaneous coronary angioplasty catheter, model 110-004, and the extreme point 9mm x80 percutaneous coronary angioplasty catheter, model 110-002: 1) a change in the lasting time from 5 seconds on and 10 seconds off to 10 seconds on and 5 seconds off; 2) a change in the fluence and repetition rate from 30-60 fluence and 25-40 hz to 30-80 fluence and 25-80 hz; 3) a labeling change from "laser advancement of approximately 1 mm per second" to "maintain constant catheter tip contact with the lesion by applying mild forward pressure to the shaft of the catheter"; and 4) a change in the pin code on the coupler so that the catheters instruct the laser system to allow increased lasing parameters.