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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.
Classification Namecatheter, electrode recording, or probe, electrode recording
Generic Namecatheter, electrode recording, or probe, electrode recording
Regulation Number870.1220
3333 diamond canyon rd.
diamond bar, CA 91765
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
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 S040 S041 S042 S043 S044 S045 S046 S047 
S048 S050