Nuvectra Corporation provided an update on its U.S. Food and Drug Administration (FDA) pre-market approval (PMA) application and its T V S D application for CE Mark in Europe for Virtis, the Company's Sacral Neuromodulation (SNM) System for the treatment of chronic urinary retention and the symptoms of overactive bladder. As part of its review of the Virtis PMA original application and the amendment submitted in April 2018, the FDA recently requested that the Company provide supplemental information related to any modifications or changes to the Virtis device, labeling and manufacturing, as well as clarifications of data related to MRI. The Company has been in active communications with the FDA and intends to promptly file comprehensive responses to address the FDA's requests. The FDA will then have up to 180 days to review the Company's responses. The Company plans to work proactively with the FDA to complete the review process as soon as possible. Also, T V S D recently informed the Company that clinical study data will be required before it can recommend approval of CE Mark for the Virtis system. The Company is continuing its discussions with T V S D regarding its application to clarify the breadth of clinical data that may be requested.