BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P980024 · Supplement: S006 · Decision Feb 27, 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
    PATHVYSION HER-2 DNA PROBE KIT
    PMA Number
    P980024
    Supplement Number
    S006
    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
    February 27, 2012
    Date Received
    October 17, 2011
    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 MANUFACTURING PROCESS CHANGES TO THE PATHVYSION HER-2 DNA PROBE KIT, INCLUDING CHANGES ASSOCIATED WITH FISH PROBE RESTRICTION ENZYMEDIGESTED GEL ELECTROPHORESIS (DNA RESTRICTION ANALYSIS), IMPLEMENTATION OF AN IN-PROCESS VALIDATED TEST METHOD FOR A260 ABSORBANCE READINGS, ADDITION OF AN INCOMING SCREENING TEST FOR DEXTRAN SULFATE AND REVISION TO MANUFACTURING PROCEDURE DOCUMENT FOR LSI HER-2/NEU AMINATED DNA.

    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