MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)

MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA) is an FDA 510(k)-cleared medical device (K030839) 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 May 29, 2003. Regulation: 8.