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BuyMyAsk

09/02/10 4:09 PM

#25434 RE: IMGGorBust #25433

Probablly the most comforting thing I have read on the board ever IMGGorBUST!!!
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IMGGorBust

09/02/10 4:12 PM

#25435 RE: IMGGorBust #25433

Even more useful information from this presentation:

Slide 45 of the video:

"We have this regulation about confidentiality really on the existence of a 510(k) application. We don't make it known publically that we have a 510(k) application under review, and we don't make anything known to the public other than those that we find SE. . . ."

All those clamoring for Dean to release more specifics about the content of the application and the specifics about what the Reviewer is communicating to Imaging3 need to understand that this is a confidential process.
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ysung

09/02/10 4:46 PM

#25438 RE: IMGGorBust #25433

Am I reading this correct ? 97% of 510k
applications are approved ??

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diannedawn

09/02/10 5:53 PM

#25447 RE: IMGGorBust #25433

"We have interactive review processes and we want to be in contact with you so you should never get an NSE determination without having heard from us if we're looking at data. Most likely you would hear from us first."

Now that is a HOOT! Neph never heard a PEEP from the FDA for 15 months and then got a NSE!

don't believe everything you read folks :)
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BigOwl47

09/02/10 6:16 PM

#25448 RE: IMGGorBust #25433

IMGGorBust, That post was very helpful. Thank you.

So the FDA is now looking at the IMGG DVis Data. That says a lot.
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ChesapeakePaddler

09/02/10 7:30 PM

#25452 RE: IMGGorBust #25433

Thanks for this post IMGGorBust. After years of waiting, it is difficult get my head around the fact that there is "at least" a 97 percent probability that approval will take place sometime over the next week. WOW.