OVALITH P-BP BIPOLAR CARDIAC PACEMAKER

OVALITH P-BP BIPOLAR CARDIAC PACEMAKER is an FDA 510(k)-cleared medical device (K800194) manufactured by Coratomic, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on February 10, 1980. Regulation: 8.