BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P910077 · Supplement: S012 · Decision Apr 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    VENTAK(R) MINI HC(HOT CAN) AICD SYSTEM
    PMA Number
    P910077
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 29, 1996
    Date Received
    September 12, 1995
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE VENTAK MINI HC (MODELS 1742, 1743, AND 1640) WHICH IS AN ACTIVE CAN VERSION OF YOUR COMMERCIALLY AVAILABLE VENTAK MINI AICD SYSTEM AND THE VENTAK MINI II HC AICD SYSTEM (MODELS 1652, 1662, 1752, 1762, 1753, AND 1763) WHICH IS A DOWN-SIZED VERSION OF THE VENTAK MINI HC AICD SYSTEM. THE MINI II HC MAXIMUM ENERGY LEVELS ARE 25 AND 27 JEWELS WHERE THE MINI HC MAXIMUM ENERGY LEVEL IS 29 JEWELS

    Classifications

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

    Product Code Device Name
    LWS Implantable Cardioverter Defibrillator (Non-Crt)