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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-CABLE 10X ETO REUSE/RESTERILIZATION, NEW EXTENSION CABLE
Generic NameCardiac ablation percutaneous catheter
ApplicantSt Jude Medical
14900 Minnetonka Ind Rd.
Minnetonka, MN 55345
PMA NumberP960016
Supplement NumberS012
Date Received07/15/2003
Decision Date11/21/2003
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 THE NEW LIVEWIRE TC CATHETER EXTENSION CABLE-STOCKERT, A NEW CABLE WITH THERMOCOUPLE SENSING ONLY FOR USE WITH THE STOCKERT 70 RADIOFREQUENCY CARDIAC ABLATION GENERATOR.
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