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Re: voo post# 22875

Monday, 05/29/2017 5:55:32 PM

Monday, May 29, 2017 5:55:32 PM

Post# of 36363
Welcome back voo. Not a bad point of seing it. I agree on that. But I think we will not get any FDA approval unless the iTbra fall in the 5% of Class I devices that requieres a 510(k) for the upgraded version. The procedures of a Class I device are purely administrative.

Just trying to clarify which are the real milestones we must expect in the coming months. We have been waiting for FDA approval since 2009 and now we may be changing this by direct US sales during 2018, in the best case scenario if Class I classification is accepted.

The difference is that if no approval is required we will have no record on the FDA website, unless someone finds out if there is a list of approved Class I devices.

Disclaimer: This information is only my opinion and should not be considered as an advice or a recommendation to investors or potential investors in relation to holding, purchasing or selling securities or other financial products or instruments.