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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(TM) CARDIAC ABLATION SYSTEM:THERMISTOR ONLY TEMPERATURE SENSING
Generic NameCardiac ablation percutaneous catheter
ApplicantSt. Jude Medical
14900 MINNETONKA IND RD
MINNETONKA, MN 55345
PMA NumberP960016
Supplement NumberS005
Date Received08/18/2000
Decision Date12/01/2000
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 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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