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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(TM) CARDIAC ABLATION SYSTEM:THERMISTOR ONLY TEMPERATURE SENSING
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation catheter
ApplicantST. JUDE MEDICAL
PMA NumberP960016
Supplement NumberS005
Date Received08/18/2000
Decision Date12/01/2000
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for eight new 4 mm tip electrode catheters with thermistor only temperature sensing. The catheters, as modified, will be marketed under the trade name livewire tc(tm) cardiac ablation system. The system is indicated for: interruption of accessory atrioventricular (av) conduction pathways assiciated with tachycardia; the treatment of av nodal re-entrant tachycardia (avnrt); or creation of complete av nodal block in patients with difficult to control ventricular response to an atrial arrhythmia.
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