BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    PMA: P910007 · Supplement: S025 · Decision Jun 10, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
    Trade Name
    AXSYM TOTAL PSA
    PMA Number
    P910007
    Supplement Number
    S025
    Device Class
    FDA Class 3
    Product Code
    MTF
    Generic Name
    Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 10, 2011
    Date Received
    January 31, 2011
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.

    Classifications

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

    Product Code Device Name
    MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer