BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P020030 · Supplement: S001 · Decision Nov 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS
    PMA Number
    P020030
    Supplement Number
    S001
    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
    November 22, 2004
    Date Received
    July 16, 2004
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE INTRODUCTION OF THE EASYTURN DEPLOYMENT MECHANISM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STELIX II EASYTURN AND IS INDICTED FOR USE WITH AN IMPLANTABLE PACEMAKER. THEY ARE INTENDED FOR PERMANENT PACING AND SENSING OF THE ATRIUM.

    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