|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||CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12|
|Classification Name||device, removal, pacemaker electrode, percutaneous|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new software version to the cvx-3000 excimer laser and revised labeling to the laser console.