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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 II COOLED ABLATION CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp
150 Baytech Dr.
San Jose, CA 95134
PMA NumberP980003
Supplement NumberS012
Date Received01/14/2004
Decision Date02/09/2004
Withdrawal Date02/28/2024
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
FOUR MANUFACTURING CHANGES: 1) CHANGE TO COOLING LUMEN EXTRUSION; 2) CHANGE TO FLUX CLEANING PROCESS; 3) CHANGE FROM 1X TO 2X KEVLAR WRAP; AND 4) CHANGE FROM MOLDED TO MACHINED DISTAL RING ELECTRODE GROOVES.
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