|Trade Name||ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|
|Classification Name||catheter, coronary, atherectomy|
|Applicant||BOSTON SCIENTIFIC CORP.|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site for the console and associated accessories located at plexus ea seattle, bothell, washington.