|Trade Name||THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS|
|Classification Name||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|
|Generic Name||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Implement an additional test system for electrical testing. Implementation of an additional test system for electrical testing.