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

    Device, Removal, Pacemaker Electrode, Percutaneous

    PMA: P960042 · Supplement: S030 · Decision Jun 8, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Device, Removal, Pacemaker Electrode, Percutaneous
    Trade Name
    SLS SPECTRANETICS LASER SHEATHS
    PMA Number
    P960042
    Supplement Number
    S030
    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
    June 8, 2011
    Date Received
    May 10, 2011
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF AN ALTERNATE SUPPLIER FOR A DEVICE COMPONENT.

    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