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LIVEWIRE TC ABLATION CATHETER (NON-IRRIGATED),SAFIRE ABLATION CATHETER (NON-IRRIGATED)

FDA premarket approval P960016/S044 · decided 2014-03-21

Approval details

PMA number
P960016
Supplement
S044
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
LIVEWIRE TC ABLATION CATHETER (NON-IRRIGATED),SAFIRE ABLATION CATHETER (NON-IRRIGATED)
Generic name
Cardiac ablation percutaneous catheter
Applicant
St Jude Medical
Date received
2013-11-27
Decision date
2014-03-21
Days to decision
114 days
Decision code
APPR
Product code
LPB
Advisory committee
Cardiovascular
Expedited review
No
Location
Minnetonka, MN
Statement
APPROVAL FOR MODIFICATION TO THE CURRENTLY MARKETED 1500T9 SERIES CARDIAC ABLATION GENERATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMPERE GENERATOR AND IS INDICATED FOR:THE AMPERE GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ABLATION CATHETERS IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT CARDIAC ARRHYTHMIAS.

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