SIMPLICI-T ANNULOPLASTY SYSTEM

SIMPLICI-T ANNULOPLASTY SYSTEM is an FDA 510(k)-cleared medical device (K052970) manufactured by Medtronic Heart Valves. 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 10, 2006. Regulation: 8.