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

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    PMA: P230009 · Supplement: S006 · Decision Apr 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
    Trade Name
    Shield
    PMA Number
    P230009
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    PHP
    Generic Name
    System, colorectal neoplasia, DNA methylation and hemoglobin detection
    Medical Specialty
    Unknown
    Advisory Committee
    Medical Genetics
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 28, 2025
    Date Received
    April 1, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval of a secondary supplier of critical raw materials, scale-up of the manufacturing process for a device component, and expansion of QC testing facilities at an existing site

    Classifications

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

    Product Code Device Name
    PHP System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection