BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P020030 · Supplement: S003 · Decision Jul 12, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    STELIX II EASY TURN LEAD MODELS BRF24D, BRF25D, BRF26D
    PMA Number
    P020030
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    NVY
    Generic Name
    Permanent defibrillator electrodes
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 12, 2006
    Date Received
    May 25, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE HELIX MECHANISM, ADDITION OF RADIOPAQUE MARKERS, AND MODIFICATIONS TO THE DEVICE INSPECTION PROCEDURES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STELIX II EASY TURN MODELS BRF24D, BRF25D, AND BRF26D AND ARE DESIGNED TO BE USED WITH AN IMPLANTABLE PACEMAKER FOR PACING AND SENSING OF THE HEART.

    Classifications

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

    Product Code Device Name
    NVY Permanent Defibrillator Electrodes