Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

[Trial of device that is not approved or cleared by the U.S. FDA]

This trial has been identified as being associated with a clinical device that has not been approved or cleared by the US Food and Drug Administration. Under the terms of US Public Law 110-85, Title VIII, Section 801, the details of this study are not available to the public.
Information provided by:
[Redacted] Identifier:
First received: March 24, 2010
Last updated: December 18, 2014
Last verified: NA

Responsible Party: [Redacted] Identifier: NCT01092871     History of Changes
Other Study ID Numbers: BMR-09-1008 
Study First Received: March 24, 2010
Last Updated: December 18, 2014
Health Authority: United States: Food and Drug Administration
Ireland: Irish Medicines Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Ministry of Health processed this record on December 09, 2016

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