Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

[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: May 8, 2012
Last updated: May 29, 2012
Last verified: NA

Responsible Party: [Redacted] Identifier: NCT01607606     History of Changes
Other Study ID Numbers: PerMIT II, 5R44HL090055-03
Study First Received: May 8, 2012
Last Updated: May 29, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration processed this record on March 03, 2015

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