|Trade Name||PRODISC-L TOTAL DISC REPLACEMENT|
|Classification Name||prosthesis, intervertebral disc|
|Generic Name||prosthesis,intervertebral disc|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - shelf-life|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an alternative package configuration for the subject ablation catheters. The new package configuration would change the previous coiled tray configuration to a tray with a straight configuration. The device, as modified, will be marketed under the trade names safire blu sp irrigated ablation catheter, therapy cool path sp (bi-directional) ablation catheter, and safire blu duo sp ablation catheter.