PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE

PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE is an FDA 510(k)-cleared medical device (K901332) manufactured by Biotronik, GmbH & Co.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 8, 1990. Regulation: 8.