BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P950022 · Supplement: S075 · Decision Dec 6, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    DURATA SJ4/DF4 FAMILIES OF HIGH VOLTAGE LEADS
    PMA Number
    P950022
    Supplement Number
    S075
    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
    December 6, 2010
    Date Received
    October 21, 2010
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE MOLDED CONNECTOR SUBASSEMBLY FOR IMPROVED MANUFACTURABILITY AND REDUCED COST FOR THE DURATA SJ4 AND DF4 HIGH VOLTAGE LEADS. CHANGES INCLUDE MINOR DESIGN, MATERIAL, AND MANUFACTURING PROCESS CHANGES. ADDITIONALLY, THE CURRENT APPROVED SUPPLIER, ACCELLENT, WILL BE PERFORMING ALL MANUFACTURING OPERATIONS RELATED TO THE MOLDED CONNECTOR SUBASSEMBLY.

    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