BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P050033 · Supplement: S001 · Decision Jul 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    COSMETIC TISSUE AUGMENTATION PRODUCT
    PMA Number
    P050033
    Supplement Number
    S001
    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 16, 2007
    Date Received
    January 3, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) AN INCREASE N THE BUFFER CONCENTRATION OF THE FINAL PRODUCT FROM 12 MM TO 50 MM SODIUM PHOSPHATE; 2) THE INTRODUCTION OF AN ANTIOXIDANT, I.E., 0.1% SODIUM METABISULFITE, INTO THE FINAL PRODUCT; AND 3) THE INTRODUCTION OF AN 0.5 ML CONFIGURATION OF COSMETIC TISSUE AUGMENTATION PRODUCT (CTA).

    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