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Edwards Lifesciences, LLC
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EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 is an FDA 510(k)-cleared medical device (K082139) manufactured by Edwards Lifesciences, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 22, 2008. Regulation: 8.