BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P000009 · Supplement: S019 · Decision Jul 26, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    VARIOUS MODELS OF ICD'S
    PMA Number
    P000009
    Supplement Number
    S019
    Device Class
    FDA Class 3
    Product Code
    MRM
    Generic Name
    DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 26, 2006
    Date Received
    June 29, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR PROGRAMMER SOFTWARE MODIFICATIONS (601.U AND A-K00.8.U) FOR USE IN BIOTRONIK PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS. THE MODIFICATIONS INCLUDED ADDING THE 1-OPT FEATURE, EXPANDING PROGRAMMER CAPABILITIES, IMPROVING PRINTING AND DATA IMPORT/EXPORT CAPABILITIES, ENHANCING COMMUNICATION AND MEMORY, UPDATING PROGRAMMABILITY AND RAM AND CORRECTING SOFTWARE ANOMALIES. THE SOFTWARE IS FOR USE WITH EPR 1000 PLUS PROGRAMMING SYSTEM, TMS 1000 PLUS PROGRAMMING SYSTEM AND ICS 3000 IMPLANT CONTROL SYSTEM.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MRM Defibrillator, Implantable, Dual-Chamber