BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tympanostomy Tube Delivery Product With Drug

    PMA: P190016 · Supplement: S002 · Decision Dec 30, 2020
    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
    S002
    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 30, 2020
    Date Received
    October 29, 2020
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a design modification to the Check Valve Assembly of the Earset of the Tula® System and for a 12-month expiration dating labeling claim for the modified Earset of Tula® System.

    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