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

    Drug-Eluting Sinus Stent

    PMA: P100044 · Supplement: S019 · Decision Oct 28, 2015
    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
    S019
    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
    October 28, 2015
    Date Received
    September 30, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDING AN INCOMING QUALITY ASSURANCE TEST FOR SHRINKAGE OF THE FIBER COMPONENTS OF THE PROPEL AND PROPEL MINI PRODUCTS AND TO INCREASE THE UPPER LIMIT FOR THE INHERENT VISCOSITY (IV) MANUFACTURING LOT RELEASE SPECIFICATION TO MATCH THE UPPER LIMIT FOR THE CURRENT IV DESIGN SPECIFICATION.

    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