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Nuvectra Provides Update on Virtis FDA PMA Submission
Jan. 30, 2019 08:40AM PST
Medical Device InvestingNuvectra (NASDAQ:NVTR), a medical device company dedicated to neuromodulation, announced today that the U.S. Food and Drug Administration (FDA) has advised that its review of Company’s pre-market approval (PMA) application for its Virtis Sacral Neuromodulation (SNM) system has been extended beyond the expiration of the FDA’s 180-day review period. As quoted in the press release: …
Nuvectra (NASDAQ:NVTR), a medical device company dedicated to neuromodulation, announced today that the U.S. Food and Drug Administration (FDA) has advised that its review of Company’s pre-market approval (PMA) application for its Virtis Sacral Neuromodulation (SNM) system has been extended beyond the expiration of the FDA’s 180-day review period.
As quoted in the press release:
Scott Drees, Chief Executive Officer, commented, “FDA has informed us that they have not yet concluded their review and as such will require an extension of our 180-day review period. To date, FDA has not identified any additional deficiencies or requested any additional information. The Company is continuing to work closely with FDA to conclude our PMA review.”