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Cirtec completes Device Master File (MAF) for their recent acquisition of the Nuvectra Algovita Spinal Cord Stimulation System
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MINNEAPOLIS (PRWEB) February 01, 2021
Cirtec Medical Corporation, a strategic outsourcing partner for complex medical devices including active implantables, minimally invasive devices and novel catheter-based delivery systems, today announced a sponsor-initiated withdrawal of the premarket approval (PMA) for the Nuvectra Algovita Spinal Cord Stimulation System. The System was an FDA and CE Mark approved neurostimulation system with no open field actions at the time of acquisition. The withdrawal of the PMA and subsequent creation of the Device Master File aligns with Cirtec’s strategy to support Academic, Research and Commercial partners with design, development, and manufacturing of active implantable device. ....

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