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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.
 
Trade NameLIVEWIRE TC CARDIAC ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation catheter
ApplicantST. JUDE MEDICAL
PMA NumberP960016
Supplement NumberS010
Date Received03/05/2003
Decision Date08/20/2004
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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