It very well could be. I'm wondering if they didnt just assume it was good because that aspect of the device remained un changed between the 2 versions, but since they changed the name of it the FDA is classifying it as a new device. Been down this road a couple times with the FDA in my real job. In fact dealing with something similar as we speak. Everytime we change the name of a product that is registered with the FDA new paperwork needs to be submitted even though that aspect of the product didn't change. Still should have been caught and dealt with but is pretty easy to overlook when your trying to get shit done ASAP.
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