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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] 26.Zheng J., Zhou Y., Li Y., Xu D.P., Li S., Li H.B

Its important to consult your healthcare provider if side effects persist or worsen

In Vitro 2015, 29, 363369