Replies to post #22019 on Grapefruit USA Inc (GPFT)

[BennyJ]

You need to go to the company news letter in IMGG website and find out. I belive original application was given SE for IDE(In August 2008 - If I remember it correct) even though it was filed for commercial clearance. Then again it was filed for SE for commercial clearance. I don't remember it exactly when it was filed again. But remember there was a long gap in 2009 when there was no response from FDA, literally no communication from FDA until September and then in November. Media created big buzz on radiation devices and FDA was approving only big boys applications and very few here and there for small and medium sized companies in 2008 & 2009. It is lot better now after new review FDA team took over in early 2010. Now the process is interactive. Hopefully soon Approval news.