|Trade Name||CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP|
|Classification Name||cardiac ablation percutaneous catheter|
|Generic Name||rf ablation system|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for five changes to address the failure of a micro switch designed to automatically shut off the pump if the roller bed cover is opened without turning off the power switch. These changes include: 1) introducing a new micro switch which features an auxiliary actuator which eliminates direct contact between the retainer screw and the actuator button; 2) adding a secondary shoulder on the retainer screw to limit the screw penetration depth to coincide with the tolerance stack up with the micro switch position; 3) minor dimension and tolerance changes to the mounting plate to accommodate the new micro switch; 4) use counter-sink holes instead of straight-through holes in the pump head to secure the mounting plate, ensuring bracket alignment and minimizing play in the bracket installation; and 5) adding an inspection step and test fixture to verify the installed position of the micro switch relative to the pump head.