BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P040024 · Supplement: S072 · Decision Jun 13, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    RESTYLANE SILK SPHAL
    PMA Number
    P040024
    Supplement Number
    S072
    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
    June 13, 2014
    Date Received
    October 21, 2013
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    14M-0872

    Advisory Committee Statement

    APPROVAL FOR RESTYLANE SILK. THIS DEVICE IS INDICATED FOR SUBMUCOSAL IMPLANTATION FOR LIP AUGMENTATION AND DERMAL IMPLANTATION FOR CORRECTION OF PERIORAL RHYTIDS IN PATIENTS OVER THE AGE OF 21.

    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