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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 THERMOCOOL, CELSIUS RMT THERMOCOOL, NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL CATHETERS
Classification Namecardiac ablation percutaneous catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP030031
Supplement NumberS042
Date Received06/19/2012
Decision Date04/12/2013
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a sterilization site located at sterigenics, s. A. , in verviers, belgium.
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