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Medtronic Neuromodulation
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SureTune4 Software is an FDA 510(k)-cleared medical device (DEN210003) manufactured by Medtronic Neuromodulation. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 22, 2021. Regulation: 8.