|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 SHEATHS (SLS)|
|Classification Name||device, removal, pacemaker electrode, percutaneous|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to establish the operating range within which the fiber winder can spool fiber for the sls and elca product lines.