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LIVEWIRE TC COMPASS STEERABLE ELECTROPHYSIOLOGY CATHETER

FDA premarket approval P960016/S004 · decided 2001-06-14

Approval details

PMA number
P960016
Supplement
S004
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
LIVEWIRE TC COMPASS STEERABLE ELECTROPHYSIOLOGY CATHETER
Generic name
Cardiac ablation percutaneous catheter
Applicant
St Jude Medical
Date received
2000-03-30
Decision date
2001-06-14
Days to decision
441 days
Decision code
APPR
Product code
LPB
Advisory committee
Cardiovascular
Expedited review
No
Location
Minnetonka, MN
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 B

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