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Edwards Lifesciences, LLC
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CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 is an FDA 510(k)-cleared medical device (K083470) 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 January 22, 2009. Regulation: 8.