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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.
 
DeviceNAVISTAR THERMOCOOL ELECTROPHYSIOLOGY CATHETER, CELSIUS THERMOCOOL ELECTROPHYSIOLOGY CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP030031
Supplement NumberS064
Date Received11/14/2014
Decision Date12/08/2014
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  
ADDITIONAL SUPPLIER FOR EXTRUSION AND BRAIDING PROCESSES.
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