BIFLEX(TM) ANNULOPLASTY RING

BIFLEX(TM) ANNULOPLASTY RING is an FDA 510(k)-cleared medical device (K902159) manufactured by St. Jude Medical, 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 January 17, 1991. Regulation: 8.