BIOTRONIK'S PS-ENDOCARDIAL LEADS

BIOTRONIK'S PS-ENDOCARDIAL LEADS is an FDA 510(k)-cleared medical device (K896824) manufactured by Biotronik, GmbH & Co.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on August 7, 1990. Regulation: 8.