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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 NameTHERMOCOOL SF CATHETERS
Classification Namecardiac ablation percutaneous catheter
Generic Nameradiofrequency generator and accessories/accessory cable
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP990071
Supplement NumberS018
Date Received06/08/2012
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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