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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameCHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP
Classification Namecardiac ablation percutaneous catheter
Generic Namerf ablation system
ApplicantBOSTON SCIENTIFIC
PMA NumberP980003
Supplement NumberS034
Date Received12/27/2011
Decision Date02/15/2012
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product 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.
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