MODIFICATION TO CARTO EP NAVIGATION SYSTEM

MODIFICATION TO CARTO EP NAVIGATION SYSTEM is an FDA 510(k)-cleared medical device (K993729) manufactured by Biosense Webster, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 2, 1999. Regulation: 8.