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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.
 
DeviceLIVEWIRE TC CARDIAC ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Applicant
St. Jude Medical
14900 minnetonka ind rd
minnetonka, MN 55345
PMA NumberP960016
Supplement NumberS043
Date Received09/19/2013
Decision Date03/12/2014
Product Code
LPB[ Registered Establishments with 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 Product No
Approval Order Statement 
Approval to semi-automate the process to decore the mandrel from the catheter shaft subassembly.
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