PROTEGE GPS SELF-EXPANDING NITINOL STENT

PROTEGE GPS SELF-EXPANDING NITINOL STENT is an FDA 510(k)-cleared medical device (K050725) manufactured by Ev3 Corporation. 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 19, 2005. Regulation: 8.