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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 DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
Classification Namecatheter, electrode recording, or probe, electrode recording
Generic Nameradiofrequency ablation catheter, electrode recording catheter
Regulation Number870.1220
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP990025
Supplement NumberS007
Date Received08/23/2002
Decision Date09/10/2002
Product Code
DRF[ Registered Establishments with DRF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing facility located at biosense webster, inc. , chihuahua, mexico.
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