BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tympanostomy Tube Delivery Product With Drug

    PMA: P190016 · Supplement: S008 · Decision Dec 22, 2023
    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
    S008
    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
    December 22, 2023
    Date Received
    June 30, 2023
    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 the sterilization of the Gen 2 Tube Delivery System (TDS) at the new contract sterilizer, Sterigenics, located in Costa Rica

    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