Since the study is designed to gather data to support a PMA or 510k the answer is maybe, maybe not. If the FDA approves the PMA based on data gathered, then they would be able to go directly to market after approval. But the FDA can always require further data subsequent to their review, possibly another trial. With all the data they've already gathered and the acceptance of Recell to date, I'd guess their chances of just having to do this one trial are decent. Time will tell, no sure answer.
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