BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P910077 · Supplement: S015 · Decision May 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    VENTAK PRX AICD, VENTAK PRX II AICD, VENTAK PRX III AICD, VENTAK MINI AICD, VENTAK MINI HC AICD, VENTAK II AICD
    PMA Number
    P910077
    Supplement Number
    S015
    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
    May 15, 1996
    Date Received
    May 10, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    Y

    Advisory Committee Statement

    APPROVAL FOR THE VENTAK PRX AICD (MODELS 1700 AND 1705), VENTAK PRX II AICD MODEL 1715, VENTAK PRX III AICD (MODELS 1720 AND 1725), VENTAK MINI AICD (MODELS 1645, 1740, 1741, 1745, AND 1746), VENTAK MINI HC AICD (MODELS 1742, 1743 AND 1640), AND VENTAK MINI AICD (MODELS 1652, 1662, 1752, 1762, 1753, AND 1763) WHICH REQUESTED APPROVAL TO ADD A PATIENT GROUP TO THE INDICATIONS FOR USE

    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)