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

    Permanent Defibrillator Electrodes

    PMA: P830061 · Supplement: S111 · Decision Aug 12, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    CAPSURE SP NOVUS LEAD, VITATRON EXCELLENCE PS+ LEAD
    PMA Number
    P830061
    Supplement Number
    S111
    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 12, 2014
    Date Received
    July 14, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    TRANSFER OF COMPONENT MANUFACTURING TO A DIFFERENT INTERNAL SUPPLIER FOR THE TWO MCRD (MONOLITHIC CONTROLLED RELEASE DEVICE) COMPONENTS USED IN THE CARDIAC LEAD MODELS.

    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