|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||SPECTRANETICS LASER SHEATH DEVICE|
|Classification Name||device, removal, pacemaker electrode, percutaneous|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an increase in the maximum repetition rate from 40 hz to 80 hz of the spectranetics laser sheath. The device, as modified, will be marketed under the trade name glidelight laser sheath.