BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

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

    PMA: P910007 · Supplement: S009 · Decision Feb 2, 2004
    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
    ABBOTT IMX TOTAL PSA
    PMA Number
    P910007
    Supplement Number
    S009
    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
    February 2, 2004
    Date Received
    January 31, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ABBOTT IMX TOTAL PSA ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ABBOTT IMX TOTAL PSA ASSAY AND IS INDICATED AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN AGED 50 YEARS OR OLDER. PROSTATIC BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF CANCER.

    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