|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 |
Change to the in-process straightness inspection criteria for the rotawire which is part of the rotablator rotational atherectomy system.