[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: March 3, 2009 No Changes Posted

Sponsored by:	TransMedics
Information provided by:	TransMedics
ClinicalTrials.gov Identifier:	NCT00855712

Responsible Party:	TransMedics ( Director of Clinical Affairs )
Study ID Numbers:	CAR-05-2008, IDE G060127
Study First Received:	March 3, 2009
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00855712 History of Changes
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 06, 2009