BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Microspheres Radionuclide

    PMA: P200029 · Supplement: S011 · Decision Feb 10, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Microspheres Radionuclide
    Trade Name
    TheraSphere
    PMA Number
    P200029
    Supplement Number
    S011
    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
    February 10, 2026
    Date Received
    September 20, 2024
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    TheraSphere are indicated for use as selective internal radiation therapy (SIRT) for local tumor control of solitary tumors (1-8 cm diameter), in patients with unresectable hepatocellular carcinoma (HCC), Child-Pugh Score A cirrhosis, well-compensated liver function, no macrovascular invasion, and good performance status.

    Classifications

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

    Product Code Device Name
    NAW Microspheres Radionuclide