BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug-Eluting Sinus Stent

    PMA: P100044 · Supplement: S050 · Decision Nov 4, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Drug-Eluting Sinus Stent
    Trade Name
    Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C
    PMA Number
    P100044
    Supplement Number
    S050
    Device Class
    FDA Class 3
    Product Code
    OWO
    Generic Name
    Drug-eluting sinus stent
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 4, 2022
    Date Received
    October 5, 2022
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for an additional control to ensure the spray coaters are running optimally during the manufacturing process.

    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