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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 CATHETERS
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp
150 Baytech Dr.
San Jose, CA 95134
PMA NumberP980003
Supplement NumberS056
Date Received01/13/2015
Decision Date04/06/2015
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 A DESIGN CHANGE TO SYSTEM CABLES FROM LEAD CONTAININGSOLDER TO LEAD-FREE SOLDER.
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