Refusal Actions by FDA as Recorded in OASIS for Sweden

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason


    Cochlear Bone Anchored Solutions AB
    Goteborg , SE SE-412 21                        CIN-DO  AEK-9412817-6/2/1
    77L--XB   BAHA INSTRUMENT SET PICK N PLACE
                        04-MAR-2008                        DEVICEGMPS

    Cochlear Bone Anchored Solutions AB
    Goteborg , SE SE-412 21                        CIN-DO  UPS-0160158-0/1/1
    77L--XB   SOUND PROCESS/DEL TO COCHLEAR, CENTENIAL,CO
                        10-MAR-2008                        DEVICEGMPS

    Q Med
    Uppsala , SE                                   NOL-DO  112-1722117-8/3/1
    80L--DQ   862425085791 MEDICAL DEVICE RESTYLANE
                        28-MAR-2008                        RXPERSONAL