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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 NameCELCIUS THERMOCOOL CATHETER,CELCIUS RMT THERMOCOOL CATHETER,NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL CATHETE
Classification Namecardiac ablation percutaneous catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP030031
Supplement NumberS055
Date Received08/09/2013
Decision Date09/05/2013
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Increasing the range of the final chamber temperature during dynamic conditioning, lowering the minimum load temperature during the ethylene oxide (eo) dwell phase, and changing of the measurement period when measuring eo concentration during the eo dwell phase.
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