|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 ROTALINK ADVANCER|
|Classification Name||catheter, coronary, atherectomy|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Alternate processing materials, and an alternate vendor used to manufacture a component of the rotablator series of devices.