|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 ANGIOPLASTY SYSTEM|
|Classification Name||catheter, coronary, atherectomy|
|Applicant||BOSTON SCIENTIFIC CORP.|
|Supplement Type|| Special Supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an additional quality control (qc) inspection method using the passage of guidewire through the rotalink plus device lumen to verify the device is free from obstructions.