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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 NumberS010
Date Received03/05/2003
Decision Date08/20/2004
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFYING THE MANUFACTURING CLEANING SOLVENT; AND CLEANING AND RESTERILIZATION OF THE CABLES UP TO TEN (10) TIMES IN EITHER A STERRAD 100S GAS PLASMA STERILIZER OR UP TO TEN (10) TIMES WITH ETO GAS STERILIZER USING THE CYCLE PARAMETERS SPECIFIED IN THE INSTRUCTIONS FOR USE.
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