LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP is an FDA 510(k)-cleared medical device (K903928) 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 October 15, 1990. Regulation: 8.