|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 GUIDEWIRE WITH WIRECLIP TORQUER|
|Classification Name||catheter, coronary, atherectomy|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Removal of 34 of the 48 quality inspections within the rotawire guidewire manufacturing process.