BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P800022 · Supplement: S050 · Decision Mar 11, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN
    PMA Number
    P800022
    Supplement Number
    S050
    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
    March 11, 2003
    Date Received
    May 16, 2001
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    03M-0114

    Advisory Committee Statement

    APPROVAL FOR COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN. THE INDICATIONS FOR USE ARE AS FOLLOWS: COSMODERM 1 HUMAN-BASED COLLAGEN AND COSMODERM 2 HUMAN-BASED COLLAGEN ARE INJECTED INTO THE SUPERFICIAL PAPILLARY DERMIS FOR CORRECTION OF SOFT TISSUE CONTOUR DEFICIENCIES, SUCH AS WRINKLES AND ACNE SCARS, AND COSMOPLAST HUMAN-BASED COLLAGEN IS INJECTED INTO THE MID TO DEEP DERMIS FOR CORRECTION OF SOFT TISSUE CONTOUR DEFICIENCIES, SUCH AS WRINKLES AND ACNE SCARS.

    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