Implantica submits U.S. FDA Premarket Approval (PMA) application for RefluxStop® (first module)
Implantica AG (publ.), a medtech company at the forefront of bringing advanced technology into the body, announces the submission of the first module of the PMA application to the U.S. FDA for RefluxStop®, an innovative device for the treatment of Gastroesophageal Reflux Disease (GERD).The U.S. FDA has agreed to a modular submission process for the RefluxStop PMA application. This process provides for ongoing review and feedback from the FDA as the modules are submitted. The second and third (final) modules are anticipated to be submitted to the FDA in three-month intervals later this year.