BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Antigen(Complexed),Prostate Specific,(Cpsa)

    PMA: P990055 · Supplement: S021 · Decision Apr 3, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Antigen(Complexed),Prostate Specific,(Cpsa)
    Trade Name
    Atellica IM Complexed PSA (cPSA) Assay
    PMA Number
    P990055
    Supplement Number
    S021
    Device Class
    FDA Class 3
    Product Code
    NAF
    Generic Name
    ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 3, 2020
    Date Received
    March 9, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Modification to the manufacturing process to add a second manufacturing site for optional sample handling subsystem (Atellica Direct Load) for the Atellica IM Analyzer (Immunoassay Module).

    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)