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

    Tympanostomy Tube Delivery Product With Drug

    PMA: P190016 · Supplement: S003 · Decision Sep 8, 2021
    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
    S003
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 8, 2021
    Date Received
    August 9, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of two new cleanrooms (Controlled Environment Rooms) to the existing manufacturing facility for the 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