BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S158 · Decision Oct 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    VIRTUOSO II ICD DR/VR MODELS
    PMA Number
    P980016
    Supplement Number
    S158
    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
    October 21, 2008
    Date Received
    September 26, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO IMPLEMENT A DESIGN CHANGE TO USE MODELS 2490C MEDTRONIC CARELINK MONITOR, 2020A CARDIOSIGHT READER, AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) TO PROVIDE PATIENTS AND DATA TRANSFER FOR THE CONCERTO II MODEL CRT-D D274TRK, VIRTUOSO II ICD MODEL DR D274DRG AND MODEL VR D274VRC DEVICES.

    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)