Mainstay Medical Announces U.S. FDA Approval of ReActiv8® Neurostimulation System for Chronic Low Back Pain
DUBLIN--(BUSINESS WIRE)--Mainstay Medical Holdings plc (“Mainstay” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Premarket Approval (PMA) application for ReActiv8®, its implantable neurostimulation system to treat intractable chronic low back pain. Jason Hannon, CEO of Mainstay, said: “I am so proud of our team and the dedicated physicians who managed our clinical trials and cared for their patients. We are thrilled to receive FDA