Mainstay Medical International plc announced that on 10 December 2019 the Company completed a Day 100 meeting with the U.S. Food and Drug Administration (FDA) regarding a Pre-Market Approval (PMA) application submission for ReActiv8. FDA generally meets with the PMA sponsor approximately 100 days after filing of the PMA for the purpose of discussing the status of the review of the application. Prior to the meeting, FDA provided Mainstay with its initial feedback on the PMA, consisting of questions regarding the data included in the PMA and the interpretation of such data. The Company currently has no plans to conduct another premarket pivotal IDE trial for ReActiv8. Mainstay will include the information requested by FDA in an amendment to the PMA, which the Company expects to file in the first quarter of 2020.