Biocompatibles International plc: Update on the Status of the Batimastat BiodivYsio -R- Stent IDE Application.Business Editors OXFORD, U.K.--(BUSINESS WIRE)--Jan. 23, 2002 On December 20, 2001 Biocompatibles (LSE LSE - Language Sensitive Editor : BII BII Bank Internasional Indonesia BII British Institute of Innkeepers BII Bioindustry Initiative (US Department of State) BII Bronco II (Ford truck; predecessor of the Explorer) BII Basic Issue Item ) filed an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) requesting the approval of the US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to start a pivotal clinical trial (BATMAN II) designed to secure a marketing authorization in the United States. The FDA has contacted Biocompatibles with a number of questions. Biocompatibles is working with the FDA to address these questions. A further announcement will be made after the FDA has reviewed the additional information. The pivotal clinical trial designed to secure CE Mark and approval in Europe (BRILLIANT II) continues to recruit patients and remains on track. |
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