BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S047 · Decision Mar 31, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    INSYNC MAXIMO MODEL 7303 ONYX VR
    PMA Number
    P980016
    Supplement Number
    S047
    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
    March 31, 2005
    Date Received
    January 21, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODELS 2490G AND 2490J CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR USE WITH THE INSYNC SENTRY MODEL 7297, INSYNC II PROTECT MODEL 7295, INSYNC MAXIMO MODEL 7303, ONYX VR MODEL 7290CX, INTRINSIC 30 MODEL 7287 AND INTRINSIC MODEL 7288 IMPLANTABLE DEVICES. THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.

    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)