BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P980023 · Supplement: S049 · Decision Feb 13, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    LINOX(SMART) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS
    PMA Number
    P980023
    Supplement Number
    S049
    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
    February 13, 2013
    Date Received
    November 14, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A NEW MODEL TO THE LINOX SMART ICD LEAD FAMILY. THIS NEW MODEL WILL BE MARKETED UNDER THE TRADE NAME LINOX SMART S DX ICD LEAD AND INDICATED FOR USE IN THE RIGHT VENTRICLE OF PATIENTS FOR WHOM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AREINDICATED; IT CAN ONLY BE USED WITH THE LUMAX VR-T DX ICD AS A SYSTEM. THE LEAD INCORPORATES TWO ATRIAL SENSING RINGS THAT REPLACE THE SVC COIL; IN ADDITION, AN IS-1 CONNECTOR WAS ADDED FOR THE ATRIAL SENSING RINGS AND THE DF-1 CONNECTOR FOR THE SVC COIL WAS REMOVED.

    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