BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S416 · Decision Jul 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    VIRTUOSO DR,VIRTUOSO VR,SECURA DR, MAXIMO II DR,VIRTUOSO II DR,SECURA VR,MAXIMO II VR,VIRTUOSO II VR,PROTECTA XT DR
    PMA Number
    P980016
    Supplement Number
    S416
    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
    July 15, 2013
    Date Received
    May 13, 2013
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CELLULAR CONNECTIVITY FOR REMOTE MONITORING WITH MODEL 2020A CARDIOSIGHT READER AND MODELS 2020B, 2020C MEDTRONIC CARELINK EXPRESS MONITORS.

    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)