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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.
 
Trade NameLIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER WITH UNIVERSAL TEMPERATURE MONITORING
Classification Namecardiac ablation percutaneous catheter
Generic Nameradio frequency-powered cardiac catheter ablation system
ApplicantST. JUDE MEDICAL
PMA NumberP960016
Supplement NumberS002
Date Received05/20/1999
Decision Date11/15/1999
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 eight new catheters marketed under the trade name livewire tc(tm) steerable electrophysiology catheter with universal temperature monitoring and the livewire tc(tm) steerable electrophysiology thermistor extension cable. The device is indicated 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 re-entrant tachycardia (avnrt); or creation of complete av nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia.
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