Atlas FDA

LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM:THERMISTOR ONLY TEMPERATURE SENSING

FDA premarket approval P960016/S005 · decided 2000-12-01

Approval details

PMA number
P960016
Supplement
S005
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM:THERMISTOR ONLY TEMPERATURE SENSING
Generic name
Cardiac ablation percutaneous catheter
Applicant
St Jude Medical
Date received
2000-08-18
Decision date
2000-12-01
Days to decision
105 days
Decision code
APPR
Product code
LPB
Advisory committee
Cardiovascular
Expedited review
No
Location
Minnetonka, MN
Statement
APPROVAL FOR EIGHT NEW 4 MM TIP ELECTRODE CATHETERS WITH THERMISTOR ONLY TEMPERATURE SENSING. THE CATHETERS, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM. THE SYSTEM IS INDICATED FOR: INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSICIATED WITH TACHYCARDIA; THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA (AVNRT); OR CREATION OF COMPLETE AV NODAL BLOCK IN PATIENTS WITH DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRH

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