BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P040024 · Supplement: S039 · Decision Jan 29, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    RESTYLANE L AND PERLANE L INJECTABLE GELS
    PMA Number
    P040024
    Supplement Number
    S039
    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
    January 29, 2010
    Date Received
    April 16, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF 0.3% LIDOCAINE INTO RESTYLANE AND PERLANE. THEDEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RESTYLANE-L AND PERLANE-L AND ISINDICATED FOR MID-TO-DEEP DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS; AND FOR IMPLANTATION INTO THE DEEP DERMIS TOSUPERFICIAL SUBCUTIS FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL FOLDS AND WRINKLES, SUCH ASNASOLABIAL FOLDS, RESPECTIVELY.

    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