Kensey Nash Updates triActiv System FDA Approval Status

Kensey Nash previously announced on Feb. 7 that the company had submitted a response to the FDA comments focused on labeling and clarification of previously submitted data in its submission for 510(k) clearance of the triActiv System. Based on recent discussions with the FDA, clearance is expected within approximately 30 days. The company's new U.S. sales team for the triActiv System has completed product training and is ready to begin selling upon receipt of FDA clearance.

MENAFN (http://menafn.com/qn_news_story.asp?StoryId=CqJE9ubWbmdC1Cde5ntm)