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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-ADDITION OF LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY
Classification Namecardiac ablation percutaneous catheter
Generic Nameradio frequency-powered cardiac catheter ablation system
ApplicantST. JUDE MEDICAL
PMA NumberP960016
Supplement NumberS001
Date Received05/06/1999
Decision Date06/18/1999
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 four curve versions of the tc(tm) catheter line with increased lateral stability, known as the xls(tm) series.
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