BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P140029 · Supplement: S033 · Decision May 27, 2022
    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 (injectable gels)
    PMA Number
    P140029
    Supplement Number
    S033
    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
    May 27, 2022
    Date Received
    September 28, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for (1) a new syringe and new plunger, new plunger rod, new finger grip, and new secondary packaging for products approved under PMA P140029; (2) implementation of these changes on a new manufacturing line (L3) for automated assembly and packaging; and (3) modification of the secondary packaging and labelling to fit the new syringe and packaging line.

    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