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LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM: BIDIRECTIONAL 4MM TIP

FDA premarket approval P960016/S007 · decided 2001-10-04

Approval details

PMA number
P960016
Supplement
S007
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM: BIDIRECTIONAL 4MM TIP
Generic name
Cardiac ablation percutaneous catheter
Applicant
St Jude Medical
Date received
2001-05-14
Decision date
2001-10-04
Days to decision
143 days
Decision code
APPR
Product code
LPB
Advisory committee
Cardiovascular
Expedited review
No
Location
Minnetonka, MN
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)

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