This study uses publicly available FDA summaries to analyze the quality of evidence in pivotal studies that support cardiovascular premarket device approval under FDA priority review from 2007 to 2017.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6584255PMC
http://dx.doi.org/10.1001/jamainternmed.2018.3649DOI Listing

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