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Sophysa SA
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POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 is an FDA 510(k)-cleared medical device (K042481) manufactured by Sophysa SA. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 13, 2004. Regulation: 8.