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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 RMT THERMOCOOL MAGNETIC STEERING CATHETERS
Generic NameCardiac ablation percutaneous catheter
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP030031
Supplement NumberS036
Date Received10/19/2011
Decision Date12/12/2011
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR EXTENDING THE SHELF LIFE FROM ONE (1) TO THREE (3) YEARS AND FOR A MINOR CHANGE TO THE THERMOFOAM TRAY USED TO PACKAGE THE DEVICES.
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