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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(TM) CARDIAC ABLATION SYSTEM: BIDIRECTIONAL 4MM TIP
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation catheter
ApplicantST. JUDE MEDICAL
PMA NumberP960016
Supplement NumberS007
Date Received05/14/2001
Decision Date10/04/2001
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 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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