BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P050037 · Supplement: S028 · Decision Jun 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    RADIESSE INJECTABLE IMPLANT
    PMA Number
    P050037
    Supplement Number
    S028
    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
    June 20, 2012
    Date Received
    March 30, 2011
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF SAFETY AND EFFECTIVENESS CLINICAL DATA AND POST-MARKETING SURVEILLANCE DATA FROM THE POST APPROVAL STUDIES PERFORMED AS A CONDITION OF APPROVAL FOR THE RADIESSE INJECTABLE IMPLANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THETRADE NAME RADIESSE INJECTABLE IMPLANT AND IS INDICATED FOR SUBDERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS AND IT IS ALSO INTENDED FOR RESTORATION AND/OR CORRECTION OF THE SIGNS OF FACIAL FAT LOSS (LIPOATROPHY) IN PEOPLE WITH HUMAN IMMUNODEFICIENCY VIRUS.

    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