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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp
150 Baytech Dr.
San Jose, CA 95134
PMA NumberP980003
Supplement NumberS034
Date Received12/27/2011
Decision Date02/15/2012
Withdrawal Date02/28/2024
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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