BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prostrate Cancer Genes Nucleic Acid Amplification Test System

    PMA: P100033 · Supplement: S004 · Decision Nov 12, 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
    S004
    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
    Approved
    Decision Code
    APPR
    Decision Date
    November 12, 2015
    Date Received
    June 10, 2015
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE INTRODUCTION OF A NEW VIAL FILLER (THE CAPMATIC LINEAR BAMBINO FILLING SYSTEM) AT THE GCD1 MANUFACTURING FACILITY.

    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