|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||SLS SPECTRANETICS LASER SHEATHS|
|Classification Name||device, removal, pacemaker electrode, percutaneous|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: sterilization|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the use of a new sterilization chamber, new sterilization cycle, change in packaging configuration for sterilization, and a change in the sterile load configuration.