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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(TM) CARDIAC ABLATION SYSTEM: BIDIRECTIONAL 4MM TIP
Generic NameCardiac ablation percutaneous catheter
ApplicantSt Jude Medical
14900 Minnetonka Ind Rd.
Minnetonka, MN 55345
PMA NumberP960016
Supplement NumberS007
Date Received05/14/2001
Decision Date10/04/2001
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CATHETER WITH A SYMMETRICALLY BIDIRECTIONAL DEFLECTABLE TIP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM: BIDIRECTIONAL 4 MM TIP AND IS INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR CARDIAC MAPPING, AND WHEN USED WITH A COMPATIBLE RADIOFREQUENCY GENERATOR FOR: 1) INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA; 2) THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA; AND 3) CREATION OF COMPLETE AV NODAL BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA.
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