BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P040024 · Supplement: S026 · Decision Jul 15, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    RESTYLANE INJECTABLE GEL
    PMA Number
    P040024
    Supplement Number
    S026
    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 15, 2008
    Date Received
    June 27, 2008
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE FOLLOWING CHANGES TO THE PRODUCT SPECIFICATIONS FOR THE PHOSPHATE BUFFER CONCENTRATE: 1) TO NARROW THE SPECIFICATION LIMIT FOR THE CONCENTRATION OF THE BUFFERING IONS IN THE PHOSPHATE BUFFER TO 23.4 ¿ 28.4 MG/ML FOR THE POTASSIUM DIHYDROGEN PHOSPHATE CONTENT AND TO 131-157 MG/ML FOR THE DISODIUM HYDROGEN PHOSPHATE CONTENT; 2) TO ADD THE BACTERIAL ENDOTOXIN TEST TO THE PHOSPHATE BUFFER CONCENTRATE SPECIFICATION; AND 3) TO ADD THE PH TEST TO THE PHOSPHATE BUFFER SPECIFICATION.

    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