PRIMUS GPS BILIARY STENT SYSTEM

PRIMUS GPS BILIARY STENT SYSTEM is an FDA 510(k)-cleared medical device (K061566) manufactured by Ev3, 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 August 30, 2006. Regulation: 8.