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Wednesday, April 24, 2019 8:06:29 AM
Milestone 7 Complete and document human
confirmatory studies under IDE protocols
for FDA submittal
Submit Technical File to European
Notified Body for review for CE Mark
Submit 510(k) application to FDA
15.1(3) Q4 2019
Looks like Europe is still on the map. Mr. McNally has previously stated that the US launch will be the initial launch, focusing on the East Coast at first (logically, to be able to concentrate resources in a smaller geographical area for start-up). I have not heard if they plan to spread further across the US or North America before the European launch, or after, or simultaneous. But it makes sense to launch in a limited area and to be able to bring additional resources to that area for training in preparation for a subsequent push into a new market area.
Before stating as fact that the EU launch is gone, maybe you should call or write to Mr. McNally and ask for any status updates regarding that topic. He is known to (occasionally) return phone calls and emails. Without any form of substantiation for the EU claim, it would appear to be false information. And we know there is NEVER any of that on this board!
Message in reply to:
Another Titan guy distancing themselves from SPORT?
Nahon was know as the French connection on the board.
Now he’s gone and so is EU launch
What’s the problem here????
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