|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||ROTAWIRE ELITE GUIDEWIRE|
|Classification Name||catheter, coronary, atherectomy|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - trade name|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a core wire vendor change and the associated rebranding of the rotawire guidewire as the rotawire elite guidewire.