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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 NameQWIKSTAR DIAGNOSTIC/ABLATION CATHETERS (MODELS D-1229 AND D-1230) AND QWIKSTAR INTERFACE CABLE (MODEL D-1195-12)
Classification Namecatheter, electrode recording, or probe, electrode recording
Generic Nameradiofrequency ablation catheter, electrode recording catheter
Regulation Number870.1220
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP990025
Supplement NumberS004
Date Received04/01/2002
Decision Date12/18/2002
Product Code
DRF[ Registered Establishments with DRF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new interface cable and design changes (e. G. , additional location sensor) to the catheter previously approved under p990025 and it's supplements, in order to enable additional mapping capabilities.
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