|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 (SLS, SLS II, AND GLIDELIGHT)|
|Classification Name||device, removal, pacemaker electrode, percutaneous|
|Supplement Type||real-time process|
|Supplement Reason|| process change: sterilization|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for parametric release for the excimer laser coronary atherectomy catheter and spectranetics laser sheath kits.