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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER WITH UNIVERSAL TEMPERATURE MONITORING
Generic NameCardiac ablation percutaneous catheter
ApplicantSt. Jude Medical
14900 MINNETONKA IND RD
MINNETONKA, MN 55345
PMA NumberP960016
Supplement NumberS002
Date Received05/20/1999
Decision Date11/15/1999
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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