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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 NameCELSIUS RMT THERMOCOOL MAGNETIC CATHETER
Classification Namecardiac ablation percutaneous catheter
Generic Namedrf(21 cfr 870.1220)
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP040036
Supplement NumberS027
Date Received10/20/2011
Decision Date12/12/2011
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
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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