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

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

    PMA: P000021 · Supplement: S025 · Decision May 28, 2013
    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
    DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE
    PMA Number
    P000021
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 28, 2013
    Date Received
    May 3, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE THE SUPPLIER FOR DEXTRAN T110 FROM SIGMA ADRICH FINE CHEMICALS(SAFC) TO PHARMACOMOS AND TO BRING PHTHALOCYANINE MANUFACTURE IN-HOUSE AT THE SIEMENSHEALTHCARE DIAGNOSTICS, NEWARK, DELAWARE SITE AND THE SCALE-UP OF THE SENSIBEAD CONCENTRATE PRODUCTION FROM 150G PER LOT SIZE TO 300G.

    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