Senza Spinal Cord Stimulation System has approvable letter from FDA.- Nevro Corp.

Nevro Corp. a medical device company that has developed and commercialized an innovative, evidence-based neuromodulation platform for the treatment of chronic pain, announced that it has received a letter from the 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.

Comment: In April 2014, Boston Scientific received FDA approval to launch its Precision Spectra device to treat chronic pain.