Clinical version approval can be found at the FDA site <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pmasimplesearch.cfm?db=pma&id=12762#aostatement" rel="nofollow" target="_blank">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pmasimplesearch.cfm?db=pma&id=12762#aostatement</a>