TS03 Inc Trust Units TSTIF

RE:The TJF-Q180 -- Again

[lematou22]

The FDA has it's own take on this week action where it substantiall takes up the memo by Olympus but it also ads some of it's own considerations.  One illustrates vividly why it has problems dealing with the Tso3 file.

As noted in FDA’s Updated Information for Healthcare Providers Regarding Duodenoscopes issued March 4, 2015, Olympus has a pending 510(k) application for its TJF-Q180V duodenoscope and the company continues to market its device while its application is under review. The removal of its device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United State of approximately 500,000 procedures per year. Update: the FDA cleared the 510(k) application on January 15, 2016.

https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm490395.htm