POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP

POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP is an FDA 510(k)-cleared medical device (K883015) manufactured by Cardiac Control Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on October 5, 1988. Regulation: 8.