BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug-Eluting Sinus Stent

    PMA: P100044 · Supplement: S048 · Decision Apr 9, 2021
    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
    S048
    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 9, 2021
    Date Received
    January 11, 2021
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the change of e-beam sterilization dose for the Propel and Propel Mini Sinus Implants.

    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