|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 |
Changes to the equipment used for the pressing, bonding and fiber optic crimping and trimming operations for the rotalink advancer and catheter which are part of the rotablator rotational atherectomy system.