POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD

POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD is an FDA 510(k)-cleared medical device (K874531) 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 January 6, 1988. Regulation: 8.