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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 CARDIAC ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation catheter
ApplicantST. JUDE MEDICAL
PMA NumberP960016
Supplement NumberS009
Date Received02/12/2003
Decision Date03/28/2003
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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