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

 
• By David Filmore

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.

FDA approved background, 3D rendering, blue street sign

[Editors' note: For sortable and searchable tables of all 2016 US and non-US approvals and clearances, check out ourApprovals Tracker.]

November was a relatively quiet month for FDA device approvals, but it was a healthy period for 510(k) clearances.

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