BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    PMA: P020027 · Supplement: S008 · Decision Mar 14, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
    Trade Name
    DIMENSION FPSA FLEX REAGENT
    PMA Number
    P020027
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    MTG
    Generic Name
    Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 14, 2008
    Date Received
    March 3, 2008
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES TO THE PRODUCT INSTRUCTIONS FOR USE: 1) ADD A NEW SECTION TITLED RISK AND SAFETY TO PROVIDE ADDITIONAL SAFETY INFORMATION ABOUT THE PRESERVATIVES PRESENT IN SOME OF THE PRODUCT REAGENTS; 2) ADD INFORMATION UNDER THE SECTION TITLED PRECAUTIONS ON THE PRESENCE OF SODIUM AZIDE, ALONG WITH HAZARD AND DISPOSAL INFORMATION; AND 3) PROVIDE FOR REFERENCE ONLY ADDITIONAL UFU CHANGES BEING IMPLEMENTED CONCURRENTLY WITH THE SAFETY INFORMATION.

    Classifications

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

    Product Code Device Name
    MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions