BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tympanostomy Tube Delivery Product With Drug

    PMA: P190016 · Supplement: S009 · Decision Jan 31, 2025
    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
    S009
    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
    January 31, 2025
    Date Received
    August 7, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for a manufacturing site located at, RxCrossroads (“Clermont Site”)170 Clermont RoadSuite AShepherdsville, KY 40165;which performs the final kitting of the Tula System Drug Pack and logistics distribution of the Tula System (Tula Kit, Drug Pack, and spares) to customers, on behalf of Tusker Medical.

    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