BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Microspheres Radionuclide

    PMA: P200029 · Supplement: S012 · Decision Apr 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
    S012
    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
    April 10, 2026
    Date Received
    March 11, 2026
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P200029/S011.

    Classifications

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

    Product Code Device Name
    NAW Microspheres Radionuclide