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

    Microspheres Radionuclide

    PMA: P200029 · Supplement: S013 · Decision Jun 4, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Microspheres Radionuclide
    Trade Name
    TheraSphere™ Y-90 Glass Microspheres System
    PMA Number
    P200029
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    NAW
    Generic Name
    Microspheres radionuclide
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 4, 2026
    Date Received
    May 12, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the ongoing quality assurance approach to ensure continued alignment with historical National Institute of Standards and Technology (NIST) traceability for TheraSphere Yttrium-90 Glass Microspheres at BWXT Medical Limited

    Classifications

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

    Product Code Device Name
    NAW Microspheres Radionuclide