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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.
 
DeviceQWIKSTAR 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 Namecatheter, electrode recording, or probe, electrode recording
Regulation Number870.1220
Applicant
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd.
diamond bar, CA 91765
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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