![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Kensey Nash Updates triActiv System FDA Approval Status
Kensey Nash Updates triActiv System FDA Approval Status
March 18, 2005
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)
KEYWORDS FDAnews Device Daily Bulletin
Upcoming Events
-
21Oct