FDAnews Device Daily Bulletin

July 25, 2012 | Vol. 9 No. 145

Medtronic Stent Graft in FDA Pilot Program

Medtronic’s Valiant Mona LSA stent graft system has been selected by the FDA as one of nine devices for an early feasibility pilot program aimed at establishing proof of concept and initial clinical safety data. The pilot is an outgrowth of the agency’s 2011 draft guidance on early feasibility clinical trials.
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