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Cardiomems, Inc.
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CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 is an FDA 510(k)-cleared medical device (K082191) manufactured by Cardiomems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 18, 2008. Regulation: 8.