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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 CARDIAC ABLATION SYSTEM
Generic NameCardiac ablation percutaneous catheter
ApplicantSt Jude Medical
14900 Minnetonka Ind Rd.
Minnetonka, MN 55345
PMA NumberP960016
Supplement NumberS033
Date Received09/27/2010
Decision Date01/07/2011
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING: FOR ONLY THE UNIDIRECTIONAL LIVEWIRE TC MODEL - A MODIFICATION OF THE TIP ATTACHMENT DESIGN AND CHANGE OF DISTAL TIP HEAT SHRINK TUBING MATERIAL FROM PTFE TO PTE. FOR BOTH THE UNIDIRECTIONAL AND BIDIRECTIONAL LIVEWIRE TC MODELS - AUTOMATION OF THE EPOXY MIXING AND APPLICATION PROCESS DURING ASSEMBLY OF THE PULL WIRE, REMOVAL OF IN-PROCESS PULL TEST REQUIREMENT, INCREASE IN THE LENGTH TOLERANCE OF THE FLAT WIRE BY 0.1 INCHES AND AUTOMATION OF THE DISPENSING OF BRAZE PASTE.
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