BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S100 · Decision Jun 14, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    VARIOUS FAMILIES OF ICD'S
    PMA Number
    P980016
    Supplement Number
    S100
    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
    June 14, 2007
    Date Received
    May 21, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE OF THREE COMPONENTS USED IN THE MANUFACTURING O 2490C MEDTRONIC CARELINK MONITOR. THE COMPONENTS BEING CHANGED ARE THE VOLTAGE CONTROLLED OSCILLATOR (VCXO) AND TWO CAPACITORS. THOSE ARE: 1) THE VCXO PROVIDES AN OUTPUT FREQUENCY IN RESPONSE TO A GIVEN VOLTAGE INPUT. FOR THE 2490C MEDTRONIC CARELINK MONITOR THE VCXO SUPPORTS THE TELEMETRY FEATURE OF THE MONITOR. THE SAME MANUFACTURER PROVIDES BOTH THE ORIGINAL PART (PART NUMBER CSX750VCB20.000MUT) AND THE NEW PART (PART NUMBER CSX750VJB20.000MUT). 2) THERE ARE TWO CAPACITORS BEING CHANGED. THE CAPACITOR AT LOCATION C230 IS CHANGING FROM 3300 PF TO 6800 PF. THE CAPACITOR AT LOCATION C277 IS CHANGING FROM 470 PF TO 6800 PF. BOTH THE CURRENT CAPACITORS AND THE NEW CAPACITORS ARE PROVIDED BY THE SAME MANUFACTURER.

    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)