PARAMOUNT MINI GPS BILIARY STENT SYSTEM

PARAMOUNT MINI GPS BILIARY STENT SYSTEM is an FDA 510(k)-cleared medical device (K040653) 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 April 27, 2004. Regulation: 8.