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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 NameNAVISTAR RMT THERMOCOOL CATHETER
Classification Namecardiac ablation percutaneous catheter
Generic Nameradiofrequency ablation catheter, electrode recording catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP030031
Supplement NumberS019
Date Received10/08/2009
Decision Date12/07/2009
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design modifications removing carto rmt connectivity from the navistar rmt thermocool catheter handle, resulting in the celsius rmt thermocool catheter.
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