Mainstay Medical Announces Acceptance For Filing by US FDA Of Pre-Market Approval Application for ReActiv8
October 01, 2019 at 02:00 am EDT
Mainstay Medical International plc announces that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Pre-Market Approval (PMA) application for ReActiv8. Mainstay submitted the PMA to the FDA in August. Per regulation, the FDA will notify the applicant whether the PMA has been accepted for filing within 45 days after submission. By accepting the Company’s PMA for filing, the FDA has made a threshold determination that the application is sufficiently complete to begin an in-depth review. Mainstay continues to expect a decision on approval around the end of 2020.