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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameNAVI-STAR 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
Date Received05/24/1999
Decision Date06/15/2000
Product Code
DRF[ Registered Establishments with DRF ]
Docket Number 00M-1388
Notice Date 07/11/2000
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: 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 S029 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S041 
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