Greatbatch Neurostim Spinoff Nuvectra to be Done Deal, Gain FDA Approval Before Year End

Monday, June 8, 2015

Source: Fierce Medical Devices

Medical device player Greatbatch ($GB) expects that the spinoff of its Algostim subsidiary will be complete by year end. Now, it's dubbed the anticipated new public company Nuvectra, whose creation was previously announced in late April. FDA approval is expected by the end of the year for Nuvectra's first product, the Algovita Spinal Cord Stimulation (SCS) system to treat chronic intractable pain of the trunk and/or limbs.

The company previously said that it received an approvable letter from the FDA for Algovita regarding its PMA submission. Agency approval of Algovita is subject to an "FDA inspection that finds the manufacturing facilities, methods and controls in compliance with the applicable requirements of the Quality System regulation," the company said in a statement. The device gained a CE mark in June 2014.

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