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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 ABLATION CATHETER
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Applicant
St. Jude Medical
14900 minnetonka ind rd
minnetonka, MN 55345
PMA NumberP960016
Supplement NumberS041
Date Received02/01/2013
Decision Date08/22/2013
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 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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