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or (2) for devices for which pass-through status will begin on or after January 1, 2020, as an alternative to the substantial clinical improvement criterion, the device is part of the FDA's Breakthrough Devices Program and has received FDA marketing authorization for the indication covered by the Breakthrough Device designation

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To evaluate the physiological relevance of these new spines and to determine the neurotransmitter signature of resident synapses, HGF treatment- induced spines labeled with mRFP-p-actin were immunostained for the universal presynaptic marker Synapsin that is located in the presynaptic active zones and the excitatory presynaptic marker VGLUTl that is found at glutamatergic presynaptic synapses