INTERMEDICS POLY FLEX EPICARDIAL SUTURE

INTERMEDICS POLY FLEX EPICARDIAL SUTURE is an FDA 510(k)-cleared medical device (K812221) manufactured by Intermedics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on October 5, 1981. Regulation: 8.