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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 4 MM BI-DIRECTIONAL DIAGNOSTIC/ABLATION CATHETERS
Classification Namecardiac ablation percutaneous catheter
Generic Nameradiofrequency ablation catheter, electrode recording catheter
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP990025
Supplement NumberS012
Date Received06/26/2006
Decision Date10/06/2006
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for using a new handle, puller wires and 1 mm location sensor.
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