BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Removal, Pacemaker Electrode, Percutaneous

    PMA: P960042 · Supplement: S049 · Decision Oct 9, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Device, Removal, Pacemaker Electrode, Percutaneous
    Trade Name
    SPECTRANETICS LASER SHEATH (SLS, SLS II, AND GLIDELIGHT)
    PMA Number
    P960042
    Supplement Number
    S049
    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
    October 9, 2014
    Date Received
    July 14, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR PARAMETRIC RELEASE FOR THE EXCIMER LASER CORONARY ATHERECTOMY CATHETER AND SPECTRANETICS LASER SHEATH KITS.

    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