CYBERLITH IMPLANTABLE PULSE GEN. #253-04

CYBERLITH IMPLANTABLE PULSE GEN. #253-04 is an FDA 510(k)-cleared medical device (K800645) manufactured by Intermedics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on April 7, 1980. Regulation: 8.