BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    PMA: P980024 · Supplement: S007 · Decision Dec 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    System, Test, Her-2/Neu, Nucleic Acid Or Serum
    Trade Name
    PATH VYSION HER-2 DNA PROBE KIT ASSAY
    PMA Number
    P980024
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    MVD
    Generic Name
    SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 20, 2012
    Date Received
    June 14, 2012
    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 MANUFACTURING CHANGE TO COMPONENTS OF THE PROBECHEK HER-2/NEU CUTOFF CONTROL SLIDES USED IN THE PATHVYSION HER-2 DNA PROBE KIT. THE CHANGE INCLUDED CREATION OF A NEW MASTER CELL BANK AND A NEW WORKING CELL BANK FROM SEED STOCK OF HS578T CELLS, USED IN THE MANUFACTURE OF THE PROBECHEK HER-2/NEU CUTOFFCONTROL SLIDES.

    Classifications

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

    Product Code Device Name
    MVD System, Test, Her-2/Neu, Nucleic Acid Or Serum