MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD

MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD is an FDA 510(k)-cleared medical device (K853410) manufactured by Intermedics, 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 October 10, 1985. Regulation: 8.