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

    Permanent Defibrillator Electrodes

    PMA: P060039 · Supplement: S001 · Decision Aug 8, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    ATTAIN STARFIX LEAD
    PMA Number
    P060039
    Supplement Number
    S001
    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
    August 8, 2008
    Date Received
    July 9, 2008
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES IN THE FOLLOWING AREAS: 1) A CHANGE IN THE CHART RECORDER TO MONITOR THE STERILIZATION PROCESS; 2) A CHANGE IN ETHYLENE OXIDE (EO) STERILIZATION EXPOSURE TIME; AND 3) A CHANGE IN THE INSPECTION METHOD OF THE COATING ON THE INNER DIAMETER OF THE TUBING COMPONENT.

    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