|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 ROTALIONAL ATHERECTOMY SYSTEM|
|Classification Name||catheter, coronary, atherectomy|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
P050019/s017 9/27/13 carotid wallstent® monorail® endoprosthesis pgsooos chilli ii® cooled ablation catheter, model8005 circucool pump, model2104 tubingkit, sterile cables boston scientific corporation maple grove mn 55311 use of new traceability/tracking software in the incoming receiving inspection area.