BIOTRONIK ENDOCARDIAL PACING LEADS

BIOTRONIK ENDOCARDIAL PACING LEADS is an FDA 510(k)-cleared medical device (K061212) manufactured by Biotronik, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on July 9, 2006. Regulation: 8.