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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 CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP990025
Supplement NumberS027
Date Received01/31/2011
Decision Date03/03/2011
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITION OF A SUPPLIER FOR CATHETER TIP ELECTRODES.
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