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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameNAVISTAR (4MM, DS, THERMOCOOL AND RMT)
Classification Namecardiac ablation percutaneous catheter
Generic Namedrf(21 cfr 870.1220)
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP040036
Supplement NumberS014
Date Received10/16/2009
Decision Date12/14/2009
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the catheter ifus to allow for additional compatibility with the carto 3 systems.
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