BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P930039 · Supplement: S123 · Decision Mar 18, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    CAPSUREFIX NOVUS, LEAD AND CAPSUREFIX , NOVUS MRI SURESCAN AND VITATRON CRYSTALLINE LEADS
    PMA Number
    P930039
    Supplement Number
    S123
    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
    March 18, 2016
    Date Received
    December 8, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a design change to the lead helix electrode and a manufacturing site change and the related update to analytical methods and tightened specifications proposed for drug related elements of the medical devices.

    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