POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD

POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD is an FDA 510(k)-cleared medical device (K854071) 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 December 3, 1985. Regulation: 8.