BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Dermal, For Aesthetic Use

    PMA: P030032 · Supplement: S012 · Decision Jul 18, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Implant, Dermal, For Aesthetic Use
    Trade Name
    HYLAFORM (HYLAN B GEL); PREVELLE SILK
    PMA Number
    P030032
    Supplement Number
    S012
    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 18, 2011
    Date Received
    May 27, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES IN THE METHODS AND SPECIFICATIONS FOR TESTING THE PREVELLE SILK FINAL PRODUCT (I.E., 1) CHANGING THE AVERAGE EXTRUSION FORCE SPECIFICATIONFROM LESS THAN 80N TO AN AVERAGE OF AVERAGE EXTRUSION FORCE SPECIFICATION OF LESS THAN 40N, 2) CHANGING THE MAXIMUM PEAK EXTRUSION FORCE SPECIFICATION OF LESS THAN 100N TO AN AVERAGE OF MAXIMUM PEAK EXTRUSION FORCE" SPECIFICATION OF LESS THAN 50N AND 3) CHANGING THE METHOD OF DETERMINING THE MAXIMUM PEAK EXTRUSION FORCE SPECIFICATION FROM THE HIGHEST SINGLE VALUE OBSERVED IN 10 SAMPLES TO AN AVERAGE OF THE MAXIMUM PEAK EXTRUSION FORCE TEST RESULTS OBSERVED IN 25 SAMPLES).

    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