MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101

MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 is an FDA 510(k)-cleared medical device (K063638) manufactured by St Jude Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 10, 2007. Regulation: 8.