|Trade Name||ATAKR(R) RFCA ABLATION SYSTEM|
|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 modification to the tip electrode length (5 mm). The device, as modified, will be marketed under the trade name conductr(r) mc-5mm, 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.