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

    Device, Removal, Pacemaker Electrode, Percutaneous

    PMA: P960042 · Supplement: S045 · Decision Dec 26, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Device, Removal, Pacemaker Electrode, Percutaneous
    Trade Name
    SPECTRANETICS LASER SHEATHS SLS
    PMA Number
    P960042
    Supplement Number
    S045
    Device Class
    FDA Class 3
    Product Code
    MFA
    Generic Name
    DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 26, 2012
    Date Received
    November 27, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF A NEW COMPUTER NUMERIC CONTROL (CNC) MACHINING TOOL.

    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