|Trade Name||ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM|
|Classification Name||cardiac ablation percutaneous catheter|
|Generic Name||cardiac ablation percutaneous catheter|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to implement design changes in the rf performr catheter that will result in the ability of the catheter to deflect in two directions rather than one and the inclusion of a self reference electrode on some models. The device, as modified, will be marketed under the trade name the rf conductr mc self-reference catheters and is indicated for the interruption of accessory atrioventricular (av) conduction pathways associated with tachycardia, for the treatment of av nodal re-entrant tachycardia, and for creation of complete av block in patients with a difficult to control ventricular response to an atrial arrhythmia.