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

    Implant, Dermal, For Aesthetic Use

    PMA: P140029 · Supplement: S034 · Decision Nov 6, 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, and Restylane Kysse
    PMA Number
    P140029
    Supplement Number
    S034
    Device Class
    FDA Class 3
    Product Code
    LMH
    Generic Name
    Implant, dermal, for aesthetic use
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 6, 2020
    Date Received
    October 7, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Changes to the distribution systems for Water for Injection (WFI) and changes to producer and distribution system of compressed air in Line 1 (L1) at Q-Med ABUppsala used for the manufacture of Restylane Refyne, Restylane Defyne, and Restylane Kysse.

    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