BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P960016 · Supplement: S033 · Decision Jan 7, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    LIVEWIRE TC CARDIAC ABLATION SYSTEM
    PMA Number
    P960016
    Supplement Number
    S033
    Device Class
    FDA Class 3
    Product Code
    LPB
    Generic Name
    Cardiac ablation percutaneous catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 7, 2011
    Date Received
    September 27, 2010
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee 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 PASTE.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LPB Cardiac Ablation Percutaneous Catheter