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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 STEERABLE ELECTROPHYSIOLOGY CATHETER ? SAFIRE MODEL
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation catheter
ApplicantST. JUDE MEDICAL
PMA NumberP960016
Supplement NumberS014
Date Received09/09/2005
Decision Date02/24/2006
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the handle design, deflection mechanism, deflection curves, materials, manufacturing processes, and packaging.
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