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

    Prostrate Cancer Genes Nucleic Acid Amplification Test System

    PMA: P100033 · Supplement: S006 · Decision Sep 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Prostrate Cancer Genes Nucleic Acid Amplification Test System
    Trade Name
    PROGENSA PCA3 ASSAY
    PMA Number
    P100033
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    OYM
    Generic Name
    Prostrate cancer genes nucleic acid amplification test system
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 24, 2015
    Date Received
    September 2, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN SUPPLIER FOR THE MAGNETIC PARTICLES (CH0206) USED IN THE MANUFACTURE OF THE PROGENSA PCA3 ASSAY FROM THERMO FISHER SCIENTIFIC TO GE HEALTHCARE.

    Classifications

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

    Product Code Device Name
    OYM Prostrate Cancer Genes Nucleic Acid Amplification Test System