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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 ABLATION CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantSt. Jude Medical
14900 MINNETONKA IND RD
MINNETONKA, MN 55345
PMA NumberP960016
Supplement NumberS041
Date Received02/01/2013
Decision Date08/22/2013
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO 1) UPDATE THE MANUFACTURING PROCEDURE TO ALLOW FOR THE USE OF A MOTORIZED STYLET FEEDER TO PUSH THE STYLET THROUGH THE CATHETER LUMEN FOR ELECTRODE STRINGING; AND 2) ADD AN ADDITIONAL STRINGING STYLET OPTION TO THE MANUFACTURING PROCEDURE.
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