BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Microspheres Radionuclide

    PMA: P990065 · Supplement: S010 · Decision Jan 18, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Microspheres Radionuclide
    Trade Name
    SIR-SPHERES MICROSPHERES
    PMA Number
    P990065
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    NAW
    Generic Name
    Microspheres radionuclide
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 18, 2017
    Date Received
    December 19, 2016
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes in device package insert with insertion of BSA model to replace the current empirical model for calculation of individual required activity dose, change of lung shunt fraction to total lung dose, less than 30 Gy to apply in the dose calculation, re-define the Radio-Embolization Induced Liver Disease (REILD) and addition of dose reduction guidance in REILD, addition of guidance of lobar therapy using BSA model, and deletion of empirical model and partition model for dose calculation.

    Classifications

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

    Product Code Device Name
    NAW Microspheres Radionuclide