|Trade Name||RF CONTACTR ABLATION CATHETER|
|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 addition of a secondary distal curve feature capable of deflections of up to 135 degrees and the removal of the variable curve reach feature and other minor design changes. The device, as modified, will be marketed under the trade name rf contactr ablation catheter and is indicated for use with a medtronic rf power generator 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.