|Trade Name||MEDTRONIC RF ENHANCR II FAMILY OF ABLATION CATHETERS|
|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 line extension to the commercially available rf enhancr catheter line with the changes limited to a new handle design and associated packaging changes. The device, as modified, will be marketed under the trade name medtronic rf enhancr ii family of ablation catheters 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.