28 UNIPOLAR AND BIPOLAR PULSE GENERATORS

28 UNIPOLAR AND BIPOLAR PULSE GENERATORS is an FDA 510(k)-cleared medical device (K790452) manufactured by Edwards Pacemaker Systems. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on May 7, 1979. Regulation: 8.