BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Acid, Hyaluronic, Intraarticular

    PMA: P940015 · Supplement: S034 · Decision Jul 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Acid, Hyaluronic, Intraarticular
    Trade Name
    SYNVISC, SYNVISC-ONE
    PMA Number
    P940015
    Supplement Number
    S034
    Device Class
    FDA Class 3
    Product Code
    MOZ
    Generic Name
    Acid, hyaluronic, intraarticular
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 24, 2015
    Date Received
    April 24, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES FOR THE DELIVERY SYRINGES FOR SYNVISC® AND SYNVISC-ONE®:1) CHANGE OF THE CLEAR PLASTIC RIGID TIP CAP (PRTC) TO A BLUE PRTC;2) CHANGE OF THE CLEAR POLYSTYRENE PLUNGER ROD, WITH DIAMETERS OF 8.0 MM AND 13.4 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES, TO A BLUE POLYPROPYLENE PLUNGER ROD WITH DIAMETERS OF 8.2 MM AND 13.7 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES; 3) CHANGE OF THE THUMB PRESS ON THE PLUNGER ROD FROM A FLAT, SMOOTH SURFACE WITH DIAMETERS OF 12.7 MM AND 18.6 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES, TO A FLAT, TEXTURED SURFACE WITH DIAMETERS OF 19 MM AND 26.7 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES; 4) CHANGE OF THE GREY PROPYLENE OVAL-SHAPED FINGER FLANGE, WITH OVERALL WIDTHS OF 28.4 MM AND 43.8 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES, TO A BLUE PROPYLENE WING-SHAPED FINGER FLANGE, WITH OVERALL WIDTHS OF 35.6 MM AND 43.9 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES; 5) CHANGE OF THE TRANSPARENT SYRINGE LABEL TO A TRANSLUCENT SYRINGE LABEL WITH GRADED BLUE COLOR; AND6) CHANGE OF THE SYNVISC-ONE® BLISTER TRAY TO INCORPORATE A FINGER FLANGE CAVITY MODIFIED TO ACCOMMODATE THE NEW FLANGE DESIGN.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SYNVISC® AND SYNVISC-ONE® AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G. ACETAMINOPHEN.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MOZ Acid, Hyaluronic, Intraarticular