|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||MAESTRO 3000 TM CARDIAC ABLATION SYSTEM|
|Classification Name||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|
|Generic Name||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|
|Supplement Type||normal 180 day track|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modification to the hardware, software, and new accessories of the ept-1000 series of cardiac ablation systems. The device, as modified, will be marketed under the trade name maestro 3000 cardiac ablation system and is indicated for use, in cardiac ablation procedures, with standard and high-power bsc cardiac ablation catheters such that the physician is referred to the individual instructions for use for catheter compatibility to the maestro 3000 cardiac ablation system. The boston scientific corporation ablation catheters which are compatible with the maestro cardiac ablation system are the blazer ii/blazer ii htd, blazer ii xp, blazer rpm , blazer xp rpm, polaris t/polaris t htd, chilli ii, and steerocath-t.