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Tuesday, August 03, 2010 9:02:56 AM
in less than a month after FDA receipt. Breakaway added a mouse taking one month in 2006. Medtronic purchased the device in 2007 for little money. In Aug 8, 2009 medtronic submits to FDA to change the indications for use and this time it took 10 months.
My question is why so fast on SE for Breakaway with a Third party review?
It would not take long for Dean to see the third party review worked for them.
I still believe we are at the end and the Dvis will receive SE but to be certain of this I must realize Dean was not as far along in his process as very longs had assumed but now bitching is mute.
One more question is a third party review the same as a radiologist review?? I did not think they were the same.
Read pg.5A form K050996
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