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US Approvals Analysis: Slow Month For PMAs, Better For 510(k)s

Executive Summary

PMA, supplement and de novo approvals from US FDA came in relatively low in November, while the agency's 510(k) clearance volume was ahead of the 2016 average. Highlighted clearances for the month include an expanded indication for Medtronic's Solitaire stent retriever system for stroke and Brightwater Medical's ConvertX nephroureteral stent system for ureteral obstructions.


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