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

    Device, Thermal Ablation, Endometrial

    PMA: P160047 · Supplement: S014 · Decision Oct 20, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Device, Thermal Ablation, Endometrial
    Trade Name
    Mara Vapor System
    PMA Number
    P160047
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    MNB
    Generic Name
    Device, thermal ablation, endometrial
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 20, 2020
    Date Received
    September 25, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Changes in manufacturing to reduce the amount of copper on the printed circuit board assembly (PCBA). These include a reduction in the amount of copper around the solder hole for the ground pin of the PCBA-mounted pressure sensor and around non-plater thru holes (NPTH).

    Classifications

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

    Product Code Device Name
    MNB Device, Thermal Ablation, Endometrial