|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||ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|
|Classification Name||catheter, coronary, atherectomy|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
New vendor for the rotalink brake spring utilized in the rotablator advancer, a component of the rotablator atherectomy system.