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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 COMPASS STEERABLE ELECTROPHYSIOLOGY CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantSt. Jude Medical
14900 MINNETONKA IND RD
MINNETONKA, MN 55345
PMA NumberP960016
Supplement NumberS004
Date Received03/30/2000
Decision Date06/14/2001
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR 1 (ONE) YEAR SHELF-LIFE, THE INCORPORATION OF ADDITIONAL ELECTRODES FOR STIMULATION AND MAPPING (10 ELECTRODES TOTAL), AND OTHER MINOR DEVICE MODIFICATIONS. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIVEWIRE TC COMPASS CATHETER AND IS INDICATED FOR USE FOR CARDIAC ELECTROPHYSIOLOGICAL. MAPPING AND FOR USE WITH A COMPATIBLE RF GENERATOR FOR: INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA; THE TREATMENT OF AV NODAL BLOCK RE-ENTRANT TACHYCARDIA (AVNRT); OR CREATION OF COMPLETION AV NODAL BLOCK IN PATIENTS WITH DIFFICULT TO CONTROL VENTRICULAR TO AN ATRIAL ARRHYTHMIA.
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