BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Antigen(Complexed),Prostate Specific,(Cpsa)

    PMA: P990055 · Supplement: S005 · Decision Sep 4, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Antigen(Complexed),Prostate Specific,(Cpsa)
    Trade Name
    IMMUNO 1 COMPLEXED PSA ASSAY
    PMA Number
    P990055
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    NAF
    Generic Name
    ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 4, 2002
    Date Received
    March 28, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES. THE LABELING CHANGES INCLUDE THE REVISION OF LITERATURE CITED IN THE SUMMARY AND EXPLANATION SECTION AND THE ADDITION OF SUMMARY DATA FROM A NEW CLINICAL STUDY. THERE IS NO CHANGE IN THE INDICATION FOR USE.

    Classifications

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

    Product Code Device Name
    NAF Antigen(Complexed),Prostate Specific,(Cpsa)