MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD

MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD is an FDA 510(k)-cleared medical device (K872126) 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 March 21, 1988. Regulation: 8.