BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P030050 · Supplement: S018 · Decision Aug 16, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    SCULPTRA AND SCULPTRA AESTHETIC
    PMA Number
    P030050
    Supplement Number
    S018
    Device Class
    FDA Class 3
    Product Code
    LMH
    Generic Name
    Implant, dermal, for aesthetic use
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 16, 2013
    Date Received
    July 22, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    THE FOLLOWING CHANGES: 1) REPLACEMENT OF THE GAMMA RADIATION SOURCE AND REQUALIFICATION OF STERILIZATION AT THE DAGNEUX FRANCE FACILITY; 2) PACKAGING MODIFICATION FOR THE RAW MATERIAL, INCLUDING A NEW BAG SUPPLIER AND THE INTRODUCTION OF A NEW BAGGING CONFIGURATION; AND 3) REPLACEMENT OF THE GAMMA RADIATION SOURCE AND REQUALIFICATION AT THE SABLÉ FRANCE FACILITY.

    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