BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P050033 · Decision Dec 20, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    HYDRELLE
    PMA Number
    P050033
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    December 20, 2006
    Date Received
    September 2, 2005
    Expedited Review
    N
    Docket Number
    06M-0531

    Advisory Committee Statement

    APPROVAL FOR THE COSMETIC TISSUE AUGMENTATION PRODUCT. THIS DEVICE IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS 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