BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Microspheres Radionuclide

    PMA: P990065 · Decision Mar 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Microspheres Radionuclide
    Trade Name
    SIR-SPHERES
    PMA Number
    P990065
    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
    March 5, 2002
    Date Received
    October 25, 1999
    Expedited Review
    N
    Docket Number
    03M-0010

    Advisory Committee Statement

    APPROVAL FOR SIR-SPHERES. THE DEVICE IS INDICATED FOR THE TREATMENT OF UNRESECTABLE METASTATIC LIVER TUMORS FROM PRIMARY COLORECTAL CANCER WITH ADJUVANT INTRA-HEPATIC ARTERY CHEMOTHERAPY (IHAC) OF FUDR (FLOXURIDINE).

    Classifications

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

    Product Code Device Name
    NAW Microspheres Radionuclide