BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P030050 · Supplement: S002 · Decision Jul 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    SCULPTRA AESTHETIC
    PMA Number
    P030050
    Supplement Number
    S002
    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
    July 28, 2009
    Date Received
    July 28, 2006
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    09M-0370

    Advisory Committee Statement

    APPROVAL FOR SCULPTRA AESTHETIC. THE DEVICE IS INDICATED FOR USE IN IMMUNE-COMPETENT PEOPLE AS A SINGLEREGIMEN FOR CORRECTION OF SHALLOW TO DEEP NASOLABIAL FOLD CONTOUR DEFICIENCIES AND OTHER FACIALWRINKLES IN WHICH DEEP DERMAL GRID PATTERN (CROSS-HATCH) INJECTION TECHNIQUE IS APPROPRIATE.

    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