Refusal Actions by FDA as Recorded in OASIS for Ireland

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


    Boston Scientific Ireland, Ltd.
    Galway , IE 1234                               NWE-DO  336-6572396-4/1/1
    74N--IQ   STENT, CORONARY, DRUG-ELUTING;;
                        03-OCT-2008                        NO PMA
                                                           UNAPPROVED

    Boston Scientific Ireland, Ltd.
    Galway , IE 1234                               NWE-DO  336-6572397-2/1/1
    74N--IQ   STENT, CORONARY, DRUG-ELUTING;;
                        03-OCT-2008                        NO PMA
                                                           UNAPPROVED

    Boston Scientific Ireland, Ltd.
    Galway , IE 1234                               NWE-DO  336-6572406-1/1/1
    74N--IQ   STENT, CORONARY, DRUG-ELUTING;;
                        03-OCT-2008                        NO PMA
                                                           UNAPPROVED

    Boston Scientific Ireland, Ltd.
    Galway , IE 1234                               NWE-DO  336-6572407-9/1/1
    74N--IQ   STENT, CORONARY, DRUG-ELUTING;;
                        03-OCT-2008                        NO PMA
                                                           UNAPPROVED

    Boston Scientific Ireland, Ltd.
    Galway , IE 1234                               NWE-DO  336-6572412-9/1/1
    74N--IQ   STENT, CORONARY, DRUG-ELUTING;;
                        03-OCT-2008                        NO PMA
                                                           UNAPPROVED

    Boston Scientific Ireland, Ltd.
    Galway , IE 1234                               NWE-DO  336-6572413-7/1/1
    74N--IQ   STENT, CORONARY, DRUG-ELUTING;;
                        03-OCT-2008                        NO PMA
                                                           UNAPPROVED

    Boston Scientific Ireland, Ltd.
    Galway , IE 1234                               NWE-DO  336-6572414-5/1/1
    74N--IQ   STENT, CORONARY, DRUG-ELUTING;;
                        03-OCT-2008                        NO PMA
                                                           UNAPPROVED

    Boston Scientific Ireland, Ltd.
    Galway , IE 1234                               NWE-DO  336-6572415-2/1/1
    74N--IQ   STENT, CORONARY, DRUG-ELUTING;;
                        03-OCT-2008                        NO PMA
                                                           UNAPPROVED

    Boston Scientific Ireland, Ltd.
    Galway , IE 1234                               NWE-DO  336-6572417-8/1/1
    74N--IQ   STENT, CORONARY, DRUG-ELUTING;;
                        03-OCT-2008                        NO PMA
                                                           UNAPPROVED

    Boston Scientific Ireland, Ltd.
    Galway , IE 1234                               NWE-DO  336-6572418-6/1/1
    74N--IQ   STENT, CORONARY, DRUG-ELUTING;;
                        03-OCT-2008                        NO PMA
                                                           UNAPPROVED

    Boston Scientific Ireland, Ltd.
    Galway , IE 1234                               NWE-DO  336-6572419-4/1/1
    74N--IQ   STENT, CORONARY, DRUG-ELUTING;;
                        03-OCT-2008                        NO PMA
                                                           UNAPPROVED

    Boston Scientific Ireland, Ltd.
    Galway , IE 1234                               NWE-DO  336-6572420-2/1/1
    74N--IQ   STENT, CORONARY, DRUG-ELUTING;;
                        03-OCT-2008                        NO PMA
                                                           UNAPPROVED

    Pfizer Ireland Pharmaceuticals
    Dublin , IE 1234                               NOL-DO  600-6315660-2/1/1
    61JDA08   Caduet (amlodipine besylate/atorvastatin calcium)
                        10-OCT-2008                        AGR RX