Module 1 contained the quality systems and manufacturing information for RefluxStop™, including the production and packaging information. FDA’s review has been completed in full and the quality systems/manufacturing module is now considered closed by FDA. Prior to formal PMA approval of RefluxStop™, FDA will perform a pre-approval inspection of the production sites to ensure the RefluxStop™ manufacturing facilities, methods, and controls are in compliance with the applicable requirements of the Quality System regulation (21 CFR part 820).

Implantica’s Founder, CEO, and Inventor of RefluxStop, Dr. Peter Forsell says, “We are grateful to FDA for their substantive review and acceptance of our Module 1 submission. We look forward to receiving FDA’s feedback on Module 2, which is expected in the very near-term and is – from our perspective – the absolutely key module that includes the remarkable 5-year Clinical study outcomes of RefluxStop™.”