BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    PMA: P910065 · Supplement: S006 · Decision Nov 30, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
    Trade Name
    AIA-PACK PA PSA, ST AIA-PACK PA PSA
    PMA Number
    P910065
    Supplement Number
    S006
    Device Class
    FDA Class 2
    Product Code
    LTJ
    Generic Name
    PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 30, 2005
    Date Received
    June 6, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS OF THE MONOCLONAL ANTIBODIES USED IN THE PRODUCTION OF THE ASSAYS AND CHANGE IN THE MANUFACTURING FACILITY USED FOR THE ABOVE MANUFACTURING PROCESS FROM NISSEIKEN CO., LTD., TOKYO, JAPAN TO TOSOH AIA, INC. IN TOYAMA, JAPAN.

    Classifications

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

    Product Code Device Name
    LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers