Implantica takes a big step forward in its RefluxStop™ U.S. approval process discussions with FDA
Implantica AG (publ) today announces feedback from its third pre-submission meeting with the U.S. Food and Drug Administration (FDA) for the approval of RefluxStop™. FDA indicated its willingness to accept a Premarket Approval (PMA) submission for review based solely on the existing long-term European data for RefluxStop™, which if approved, would allow for U.S. market entry without a premarket U.S. clinical trial.Implantica received helpful feedback from the FDA in its recent supplemental pre-submission meeting where the regulatory pathway of RefluxStop™ was discussed. Due to the favorable
