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njk11

10/29/09 9:23 PM

#4396 RE: dayneyus #4395

My understanding is that its a language issue. Its merely verbiage, as opposed to anything physical about the device. For legal reasons they need the language promising the right things to make sure it matches the use and reason of how they would approve it.

This is great news secondary to full out approval. Its implied (though nothing is certain) that they have approved everything else.
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chevyman

10/29/09 10:30 PM

#4399 RE: dayneyus #4395

I was curious about that also, I wonder when he narrowed it? Oh well, the FDA was quick on this responce, hopefully as quick on the label!