BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Removal, Pacemaker Electrode, Percutaneous

    PMA: P960042 · Supplement: S056 · Decision Apr 24, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Device, Removal, Pacemaker Electrode, Percutaneous
    Trade Name
    ELCA and SLS/GlideLight Catheter
    PMA Number
    P960042
    Supplement Number
    S056
    Device Class
    FDA Class 3
    Product Code
    MFA
    Generic Name
    DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 24, 2017
    Date Received
    April 7, 2017
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval to add an additional in-process endotoxin test to the extruded components of the catheters.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MFA Device, Removal, Pacemaker Electrode, Percutaneous