|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||LASER SHEATH|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an increase in the laser "on" time to 10 seconds and a decrease in the laser "off" time to 5 seconds. These devices are indicated for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.