BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P830061 · Supplement: S086 · Decision Feb 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    CAPSURE SENSE LEAD
    PMA Number
    P830061
    Supplement Number
    S086
    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
    February 18, 2014
    Date Received
    March 13, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REMOVAL OF THE DEXAMETHASONE SODIUM PHOSPHATE (DSP) COATING FROM THE LEAD TIP AND THE MANUFACTURING SITE CHANGE FOR THE MONOLITHIC CONTROLLED RELEASE DEVICE (MCRD) FOR THE CAPSURE SENSE FAMILY OF 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