MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT

MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT is an FDA 510(k)-cleared medical device (K032360) manufactured by Boston Scientific Corp. 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 26, 2003. Regulation: 8.