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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.
 
DeviceNAVISTAR AND CELSIUS DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETERS
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 NumberS006
Date Received06/07/2002
Decision Date04/22/2003
Product Code
DRF[ Registered Establishments with DRF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason other report
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the sterilization cycle parameters (from conventional ethylene oxide processing to eo express).
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