BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P030050 · Supplement: S017 · Decision Oct 10, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID)
    PMA Number
    P030050
    Supplement Number
    S017
    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 10, 2014
    Date Received
    April 5, 2013
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN PRODUCT LABELING TO DESCRIBE THE RESULTS OF A POSTAPPROVAL STUDY IN PATIENTS WITH HIV ASSOCIATED LIPOATROPHY.

    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