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Re: lennygoat post# 5506

Tuesday, 11/24/2009 6:39:04 PM

Tuesday, November 24, 2009 6:39:04 PM

Post# of 59549
i don't think the FDA gives any thought to when the RSNA show is, they are going to send the approval letter when the device is approved.
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I absolutely agree...

I am hopeful, and would not be surprised, if it came during the RSNA show. I would be very surprised if they surfaced a new issue. We have been in the process for a long time and have pretty well worked through their concerns. The last time there were only the questions about the label.

Dean, who has succesfully been through this process with the FDA several times, really seems to expect approval soon... he even mentioned by the end of the month.

Hopefully the person (at FDA) who sent this last inquiry didn't take a week of vacation around the Thanksgiving break.

At any rate, it shouldn't be long now...Best to all!