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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 DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS
Classification Namecardiac ablation percutaneous catheter
Generic Nameradiofrequency ablation catheter, electrode recording catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP030031
Supplement NumberS005
Date Received04/03/2007
Decision Date01/04/2008
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the navistar thermocool catheter design so that it is compatible with the stereotaxis niobe magnetic navigation system.
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