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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceNAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
Generic NameCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Regulation Number870.1220
ApplicantBIOSENSE WEBSTER, INC.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP990025
Date Received05/24/1999
Decision Date06/15/2000
Product Code DRF 
Docket Number 00M-1388
Notice Date 07/11/2000
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE NAVI-STAR(R) DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER. THE NAVI-STAR DIAGNOSTIC/ABLATION CATHETER, AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR CARDIAC MAPPING, AND WHEN USED WITH A COMPATIBLE RADIO FREQUENCY GENERATOR IN ADULTS AND CHILDREN 4 YEARS OF AGE AND OLDER FOR:* INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA; INCLUDING PERSISTEND JUNCTIONAL RE-ENTRANT TACHYCARDIA (PJRT) ...
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S029  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S021 S022 S023 S024 
S025 S026 S027 S028 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 
S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 
S062 S063 S064 S065 S066 S067 S068 S069 S070 S071 
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