Atlas FDA

LIVEWIRE TC CARDIAC ABLATION SYSTEM

FDA premarket approval P960016/S033 · decided 2011-01-07

Approval details

PMA number
P960016
Supplement
S033
Supplement type
Real-Time Process
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
LIVEWIRE TC CARDIAC ABLATION SYSTEM
Generic name
Cardiac ablation percutaneous catheter
Applicant
St Jude Medical
Date received
2010-09-27
Decision date
2011-01-07
Days to decision
102 days
Decision code
APPR
Product code
LPB
Advisory committee
Cardiovascular
Expedited review
No
Location
Minnetonka, MN
Statement
APPROVAL FOR THE FOLLOWING: FOR ONLY THE UNIDIRECTIONAL LIVEWIRE TC MODEL - A MODIFICATION OF THE TIP ATTACHMENT DESIGN AND CHANGE OF DISTAL TIP HEAT SHRINK TUBING MATERIAL FROM PTFE TO PTE. FOR BOTH THE UNIDIRECTIONAL AND BIDIRECTIONAL LIVEWIRE TC MODELS - AUTOMATION OF THE EPOXY MIXING AND APPLICATION PROCESS DURING ASSEMBLY OF THE PULL WIRE, REMOVAL OF IN-PROCESS PULL TEST REQUIREMENT, INCREASE IN THE LENGTH TOLERANCE OF THE FLAT WIRE BY 0.1 INCHES AND AUTOMATION OF THE DISPENSING OF BRAZE PA

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