PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP

PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP is an FDA 510(k)-cleared medical device (K910608) 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 July 29, 1991. Regulation: 8.