CYBERLITH IMPLANTABLE PULSE GEN. #253-02

CYBERLITH IMPLANTABLE PULSE GEN. #253-02 is an FDA 510(k)-cleared medical device (K800644) 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 15, 1980. Regulation: 8.