|Trade Name||RF ENHANCER 7 FRENCH, 5 MM 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 ablation catheters which feature design changes to the performer catheter. The device, as modified, will be marked under the trade name rf enhancer 7french, 5 mm ablation catheter and is indicated for use with the medtronic rf power generator to deliver rf energy for intracardiac ablation 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.