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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.
Classification Namecardiac ablation percutaneous catheter
Generic Nameradio frequency-powered cardiac catheter ablation system
PMA NumberP960016
Supplement NumberS004
Date Received03/30/2000
Decision Date06/14/2001
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1 (one) year shelf-life, the incorporation of additional electrodes for stimulation and mapping (10 electrodes total), and other minor device modifications. The device as modified, will be marketed under the trade name livewire tc compass catheter and is indicated for use for cardiac electrophysiological. Mapping and for use with a compatible rf generator for: interruption of accessory atrioventricular (av) conduction pathways associated with tachycardia; the treatment of av nodal block re-entrant tachycardia (avnrt); or creation of completion av nodal block in patients with difficult to control ventricular to an atrial arrhythmia.