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Medtronic PS Medical
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MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855 is an FDA 510(k)-cleared medical device (K012052) manufactured by Medtronic PS Medical. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 10, 2002. Regulation: 8.