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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 AND CABLE
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp.
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP980003
Supplement NumberS042
Date Received09/19/2013
Decision Date10/18/2013
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
CHANGE TO IMPLEMENT THE CENTRAL MONITORING SYSTEM (CMS) AT THE STERILIZATION FACILITY.
Post-Approval StudyShow Report Schedule and Study Progress
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