MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM

MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM is an FDA 510(k)-cleared medical device (K092455) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 2009. Regulation: 8.