Nevro Corp, a medical device company that has developed and commercialised an innovative, evidence-based neuromodulation platform for the treatment of chronic pain, announced that it has received a letter from the US 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 FDAs Quality System Regulation, as well as finalisation of the products labelling with the FDA.
Posted on: Tue, 27 Jan 2015 07:17:25 +0000
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