BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P930039 · Supplement: S135 · Decision Jul 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD
    PMA Number
    P930039
    Supplement Number
    S135
    Device Class
    FDA Class 3
    Product Code
    NVY
    Generic Name
    Permanent defibrillator electrodes
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 16, 2015
    Date Received
    July 1, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MOVE THE WIRE DRAWING PROCESS FOR THE PLATINUM IRIDIUM WIRE USED IN A HELIX COMPONENT FROM THE HERAEUS HANAU, GERMANY FACILITY TO THE HERAEUS SINGAPORE FACILITY.

    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