PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM

PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K033314) 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 November 20, 2003. Regulation: 8.