BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S331 · Decision Feb 28, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/PROTECTO/PROTECTO XT/SECURA/VIRTUOSO/VIRTUOSO II/PROTECTA XT DR/PROTECTA DR
    PMA Number
    P980016
    Supplement Number
    S331
    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
    February 28, 2013
    Date Received
    November 21, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE ENTRUST, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO, VIRTUOSO II, PROTECTA XT DR, AND PROTECTA DR ICDS.

    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)