BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P020023 · Supplement: S012 · Decision Oct 21, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    RESTYLANE
    PMA Number
    P020023
    Supplement Number
    S012
    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
    October 21, 2005
    Date Received
    June 6, 2005
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR PERFORMING THE PROTEIN TESTING IN-HOUSE AT THE Q-MED QUALITY CONTROL LABORATORY AND TO CHANGE THE TEST METHOD SO AS TO ALLOW FOR THE DETECTION OF LOWER AMOUNTS OF PROTEIN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RESTYLANE AND IS INDICATED AS AN INJECTABLE GEL FOR AESTHETIC USE.

    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