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Under this alternative pathway, a medical device that has received FDA marketing authorization (that is, has been approved or cleared by, or had a De Novo classification request granted by, FDA) as a Breakthrough Device, for the indication covered by the Breakthrough Device designation, will need to meet the requirements of 412.87(c)

[DOI] [PMC free article] [PubMed] [Google Scholar] 182.Yu K., Wang Y., Wan T., Zhai Y., Cao S., Ruan W., Wu C., Xu Y

Identification of rat Gas7 isoforms differentially expressed in brain and regulated following kainate-induced neuronal injury

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