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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 BI-DIRECTIONAL AND UNI-DIRECTIONAL CATHETERS
Classification Namecardiac ablation percutaneous catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP030031
Supplement NumberS039
Date Received02/21/2012
Decision Date06/15/2012
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternative sterilization facility located at sterigenics us in santa teresa, new mexico.
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