Guys, there is only so much I can tell. The FDA has already recieved images and this is not the reason for this level of approval. I cannot imply what it means as it would be biased, but as a development it is an important step through the process as I believe the FDA would be hard pressed to allow a device to be used on a patient they feel they have problems with?? To be allowed to distribute opens some doors, but one should consider where the companies best use of time would be distributing products or achieving full approval.
Patience is important, this information should be very helpful for those of you who doubt the "if" of FDA approval and help you along with the "When"...
Dean
Market Data 
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