|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||BLAZER II XP/PRIME XP CATHETER|
|Classification Name||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|
|Generic Name||radiofrequency generator/cardiac ablation catheter|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for packaging design change for the blazer ii/prime htd catheters electrophysiology cables, models m0046130 and m0046510; chilli cooled ablation system electrophysiology cables, models m0046810 and m004620620; and blazer ii xp and blazer prime cardiac ablation catheters electrophysiology cables, models m0046130 and m0046510.