BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tympanostomy Tube Delivery Product With Drug

    PMA: P190016 · Supplement: S007 · Decision Feb 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Tympanostomy Tube Delivery Product With Drug
    Trade Name
    Tula® System
    PMA Number
    P190016
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    QJA
    Generic Name
    Tympanostomy tube delivery product with drug
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 1, 2024
    Date Received
    April 5, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    which requested approval for modifications to the design of the Iontophoresis System (IPS) Earset and Tube Delivery System (TDS) components of the Tula System, collectively described as the next generation (“Tula Gen 2”), as well as modifications to the Tula System packaging configuration and tray sealing. Finally, your supplement requested approval for a Predetermined Change Control Plan (PCCP) for an alternate microcontroller component.

    Classifications

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

    Product Code Device Name
    QJA Tympanostomy Tube Delivery Product With Drug