MAINSTAY MEDICAL: Good news for ReActiv8 in the United States – Indices & Actions

(AOF) – Mainstay Medical International announced Tuesday that the US Drug Administration (FDA) has accepted the filing of the Pre-Market Approval (PMA) application for ReActiv8 in the United States. Mainstay made this deposit in August. According to the regulations, the FDA has 45 days from the deposit to accept it. This acceptance means that the FDA has found the file sufficiently comprehensive to undertake a thorough review. Mainstay continues to believe that a decision on approval could be made around the end of 2020.

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