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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 CARDIAC ABLATION SYSTEM
Generic NameCardiac ablation percutaneous catheter
ApplicantSt Jude Medical
14900 Minnetonka Ind Rd.
Minnetonka, MN 55345
PMA NumberP960016
Supplement NumberS009
Date Received02/12/2003
Decision Date03/28/2003
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REVISED INDICATIONS FOR USE FOR THESE MODELS OF LIVEWIRE TC ABLATION CATHETERS: 5MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETERS XLS WITH UNIVERSAL SENSOR (MODELS 402205-402208); 5MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETERS XLS WITH THERMISTOR (MODELS 402209-402212); 5MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETERS XLS WITH THERMOCOUPLE (MODELS 402213-402216); 4MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETHER WITH THERMISTOR (MODELS 402229-402232); AND 4MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER XLS WITH THERMISTOR (MODELS 402233-402236). THE CATHETERS ARE INDICATED FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND FOR USE WITH A COMPATIBLE RF GENERATOR FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS.
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