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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 CATHETER,NAVISTAR RMT THERMOCOOL CATHETER,EZ STEER THERMOCOOL CATHETER,EZ STEER THERMOCOOL NAV CATH
Generic NameCardiac ablation percutaneous catheter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP040036
Supplement NumberS041
Date Received12/27/2013
Decision Date01/24/2014
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  
CHANGE IN THE STERILIZATION RELEASE METHOD FOR BIOSENSE WEBSTER CATHETERS AND CABLES.
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