BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P980024 · Decision Dec 11, 1998
    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
    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 11, 1998
    Date Received
    June 16, 1998
    Expedited Review
    N
    Docket Number
    99M-0034

    Advisory Committee Statement

    Approval for the PathyVysion(TM) HER-2 DNA Probe Kit. The PathyVysion(TM) HER-2 DNA Probe Kit (PathyVysion Kit) is designed to detect amplification ofthe HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded human breast cancer tissue speciments. Results from the PathVysion Kit are intended for use as an adjuncto to existing clinical and pathologic information currently used as prognostic factors in state II, node-positive breast cancer patients. The PathVysion Kit is further indicated as an aid in predct disease-free and overall survival in patients with stage II, node positive breast cancer treated with adjuvant cyclophosphamide, dosorubicin, and 5-fluorouracil (CAF) chemotherapy.

    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