|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.|
|Trade Name||SIMPSON CORONARY ATHEROCATH-SCA-EX, GTO AND BANTAM ATHERECTOMY CATHETERS|
|Classification Name||catheter, coronary, atherectomy|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the labeling for the simpson coronary atherocath(r) sca-ex(tm), gto(r), and bantam(tm) atherectomy catheters to 1) include clinical data from the balloon versus optimal atherectomy trial (boat) and 2) streamline the remainder of the text.