|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|
|Classification Name||device, removal, pacemaker electrode, percutaneous|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification to the 12f and 14f laser sheath kits (models 500-001 and 500-012).