[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.

Sponsored by:	Vascutek Ltd.
Information provided by:	Vascutek Ltd.
ClinicalTrials.gov Identifier:	NCT00608647

Responsible Party:	Vascutek Ltd., a Terumo Company (product legal manufacturer) ( Dr Karen Kelso Regulatory Affairs Manager )
Study ID Numbers:	Rap-001, G060186
First Received:	January 22, 2008
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00608647
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 03, 2008