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

    Drug-Eluting Sinus Stent

    PMA: P100044 · Supplement: S056 · Decision Feb 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Drug-Eluting Sinus Stent
    Trade Name
    Propel®, Propel® Mini, Propel® Contour Sinus Implants
    PMA Number
    P100044
    Supplement Number
    S056
    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
    February 12, 2025
    Date Received
    January 16, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    adding Medtronic North Haven Laboratory Services (Medtronic-North Haven) as an alternate test facility for in-process bioburden monitoring and periodic sterility testing of the Propel Product Family (Propel Sinus Implant, Propel Mini Sinus Implant, Propel Contour Sinus Implant, and Propel Mini Sinus Implant with Straight Delivery System)

    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