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

    Drug-Eluting Sinus Stent

    PMA: P100044 · Supplement: S021 · Decision Jun 17, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Drug-Eluting Sinus Stent
    Trade Name
    PROPEL AND PROPEL MINI SINUS IMPLANTS
    PMA Number
    P100044
    Supplement Number
    S021
    Device Class
    FDA Class 3
    Product Code
    OWO
    Generic Name
    Drug-eluting sinus stent
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 17, 2016
    Date Received
    May 18, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Modification of two packaging related processes: 1) the addition of an automated Desiccant Dispenser to automatically dispense the desiccants used in the manufacturing product packaging; and 2) the addition of a semi-automated Component Verification System for verifying the presence of components during packaging. These changes are being made to implement the addition of two new equipment systems to facilitate the conversion from manual to automated processes

    Classifications

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

    Product Code Device Name
    OWO Drug-Eluting Sinus Stent