Nevro Receives Approvable Letter from U.S. Food and Drug Administration for Senza® Spinal Cord Stimulation System
Nevro to Host Investor Conference Call Friday, January 23 at 8:30 a.m. ET
MENLO PARK, Calif., Jan. 22, 2015 -- Nevro Corp. (NVRO), a medical device company that has developed and commercialized an innovative, evidence-based neuromodulation platform for the treatment of chronic pain, today announced that it has received a letter from the U.S. Food and Drug Administration (FDA) informing the company of the approvability of its Premarket Approval Application (PMA) for the Senza spinal cord stimulation (SCS) system. According to the approvable letter, approval of the PMA is subject to satisfaction of regulatory inspections and audits of manufacturing facilities, methods and controls for Senza to ensure compliance with the FDA's Quality System Regulation, as well as finalization of the product's labeling with the FDA.
- Published: 23 January 2015
- Written by Editor
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