|Trade Name||BLAZER PRIME XP CARDIAC ABLATION CATHETER|
|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 no user fee|
|Supplement Reason|| location change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at boston scientific corporation in heredia, costa rica.