BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P140029 · Supplement: S031 · Decision Dec 4, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels
    PMA Number
    P140029
    Supplement Number
    S031
    Device Class
    FDA Class 3
    Product Code
    LMH
    Generic Name
    Implant, dermal, for aesthetic use
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 4, 2020
    Date Received
    September 14, 2020
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval of changes to the Line 3 cleanrooms 9:169, 9:170, 9:177 and 9:190 in Facility 2, Building 9 at Q-Med ABs site located at Seminariegatan 21, SE-752 58 Uppsala, Sweden, used for the manufacturing of Restylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LMH Implant, Dermal, For Aesthetic Use