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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
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp
150 Baytech Dr.
San Jose, CA 95134
PMA NumberP980003
Supplement NumberS025
Date Received10/18/2010
Decision Date04/08/2011
Withdrawal Date02/28/2024
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR TEN DESIGN CHANGES TO THE CIRCUCOOL MODEL 8005 PUMP SYSTEM TO ADDRESS STOPPAGE AND MOTOR NOISE COMPLAINTS. THESE CHANGES INCLUDE: 1) CHANGING A SCHOTKY DIODE FROM ON SEMICONDUCTOR¿S 1N5822 (40V MAXIMUM REVERSE VOLTAGE) TO ON SEMICONDUCTOR¿S MBR360 (60V MAXIMUM REVERSE VOLTAGE). 2) ADDITION OF A 33.3V VOLTAGE SUPPRESSOR (ON SEMICONDUCTOR P6KE39AG) ACROSS MOTOR TERMINALS AT THE MOTOR. 3) DIMENSIONAL AND TOLERANCE REVISIONS TO THE ROLLER SLEEVE, SHAFT ROTOR AND ROLLER COMPONENTS.
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