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St Jude Medical
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MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000 is an FDA 510(k)-cleared medical device (K070902) manufactured by St Jude Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 2007. Regulation: 8.