[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.

First Received: October 3, 2008 No Changes Posted

Sponsored by:	W.L.Gore & Associates
Information provided by:	W.L.Gore & Associates
ClinicalTrials.gov Identifier:	NCT00766493

Responsible Party:	W.L. Gore and Associates ( Donald H. Harkness/Clinical Affairs Leader )
Study ID Numbers:	GEF-06-08
Study First Received:	October 3, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00766493 History of Changes
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 07, 2009