|Trade Name||MEDTRONIC MODEL 4819 ABLATION CATHETER TO EP RECORDING SYSTEM CABLE|
|Classification Name||cardiac ablation percutaneous catheter|
|Generic Name||cardiac ablation percutaneous catheter|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a cable that will allow a medtronic radio-frequency ablation catheter to function as a diagnostic catheter by providing connectivity to an ep recording system. The device, as modified, will be marketed under the trade name medtronic model 4819 ablation catheter to ep recording system cable and is indicated for use during diagnostic electrophysiologic studies in conjunction with medtronic electrode catheters. The cable is used during electrophysiology studies to connect the electrode catheter to the ecg recording/ stimulation equipment.