Some seem to have short or selective memories
It has been indicated from a couple of sources that at or about the time of the 510k Substantive Review, 60 day mark, there was an FDA request for further information.
It has also been indicated that BIEL has supplied this information to the FDA. What is not readily known is the exact number of days that the FDA Clock was stopped while BIEL compiled its response to the FDA.
Example, It is currently day 92 since submission. Say BIEL received a information request on day 60, the Clock stops. Say BIEL took 10 days to gather the information and submit it to the FDA. That scenario would make the FDA Clock at 82 days instead of 92. This is just an example. I have no information that it was 10 days.
The Back/Full Body Clearance will happen. Relax and enjoy the ride.
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