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

    Permanent Defibrillator Electrodes

    PMA: P950024 · Supplement: S010 · Decision May 14, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    CAPSURE EPI EPICARDIAL STEROID ELUTING PACING LEAD
    PMA Number
    P950024
    Supplement Number
    S010
    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
    May 14, 2008
    Date Received
    April 14, 2008
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO THE RICE CREEK FACILITY?S ETHYLENE OXIDE (ETO) STERILIZATION EXPOSURE TIME FOR LEADS, PACING ACCESSORIES, AND ADAPTOR PRODUCTS.

    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