|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||SPECTRANTICS SLS II LASER SHEATH|
|Classification Name||device, removal, pacemaker electrode, percutaneous|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Removal of a qc step that verifies the fiber bundle alignment.