The first graph shows the progression from Receipt of I.D.E to First patient enrollment.
The second diagram shows how the E.F.S study will transition to the Pivotal I.D.E study, then onto the P.M.A. submission for full device market approval.
We still have more hoops to jump through but heading in the right direction!
Good times ahead
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- Ann: FDA Approves Early Feasibility Study for DurAVR THV System
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Ann: FDA Approves Early Feasibility Study for DurAVR THV System, page-24
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