MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)

MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS) is an FDA 510(k)-cleared medical device (K022026) manufactured by Medtronic Ave, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 18, 2002. Regulation: 8.