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Advanced Neuromodulation Systems CE-marks Genesis IPG (implantable pulse generator) system:

Advanced Neuromodulation Systems has CE-marked for sale in Europe its Genesis totally implantable pulse generator spinal cord stimulator for pain relief. The Plano, Texas-based company says a decision is expected imminently from the US FDA as to whether the product can be reclassified as a class II device (from class III). The reclassification will allow ANS to submit the device to the FDA via the 510(k) marketing clearance process rather than the PMA route, which usually involves a longer procedure.

Advanced Neuromodulation Systems has CE-marked for sale in Europe its Genesis totally implantable pulse generator spinal cord stimulator for pain relief. The Plano, Texas-based company says a decision is expected imminently from the US FDA as to whether the product can be reclassified as a class II device (from class III). The reclassification will allow ANS to submit the device to the FDA via the 510(k) marketing clearance process rather than the PMA route, which usually involves a longer procedure.

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