BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P020012 · Decision Oct 27, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER
    PMA Number
    P020012
    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 27, 2006
    Date Received
    April 1, 2002
    Expedited Review
    N
    Docket Number
    06M-0455

    Advisory Committee Statement

    APPROVAL FOR THE ARTEFILL, WHICH IS INDICATED FOR CORRECTION OF NASOLABIAL FOLDS.

    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