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

    Permanent Defibrillator Electrodes

    PMA: P030036 · Supplement: S080 · Decision Nov 18, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    SELECTSECURE LEAD
    PMA Number
    P030036
    Supplement Number
    S080
    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
    November 18, 2015
    Date Received
    October 23, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES TO PASSIVATION PROCESS PARAMETER SETTINGS AND UPDATES TO SAMPLE SIZES USED FOR IN PROCESS/FINAL INSPECTION AT A SUPPLIER FOR SEVERAL COMPONENTS OF THE SUBJECT LEADS.

    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