BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug-Eluting Sinus Stent

    PMA: P100044 · Supplement: S045 · Decision Apr 24, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Drug-Eluting Sinus Stent
    Trade Name
    Propel Family of Sinus Implants
    PMA Number
    P100044
    Supplement Number
    S045
    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
    April 24, 2020
    Date Received
    March 26, 2020
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modifications to the Instructions for Use (IFU) to enhance the safe use of the Propel Family of Implants (Propel, Propel Mini and Propel Contour).

    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