|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: packaging|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Modifications to reduce the frequency of sterile barrier strength testing and a modification to the process of seal strength monitoring.