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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 NumberS013
Date Received08/30/2004
Decision Date10/14/2004
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 CHANGES MADE TO THE INTERNAL DISTAL TIP CONFIGURATION AND THE CATHETER SHAFT AS WELL AS CHANGES IN THE MANUFACTURING PROCESS TO BOND THE STEERING MECHANISM TO THE BRAIDED SHAFT FOR THE CHILLI II CARDIAC ABLATION CATHETER.
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