BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P950037 · Supplement: S046 · Decision Dec 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    LUMAX IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)
    PMA Number
    P950037
    Supplement Number
    S046
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 7, 2006
    Date Received
    September 11, 2006
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE LUMAX IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS), MODELS 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T AND 340 HF-T AND PROGRAMMER SOFTWARE VERSION 603.U FOR USE WITH THE LUMAX FAMILY OF ICDS AND BIOTRONIK, INC. PACERS, SINGLE CHAMBER ICDS AND DUAL CHAMBER ICDS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMAX, AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND/OR FOR PROVIDING TREATMENT OF CONGESTIVE HEART FAILURE.

    Classifications

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

    Product Code Device Name
    NVZ Pulse Generator, Permanent, Implantable