PRIMA-UNIPOLAR CARDIAC PULSE GENERAT

PRIMA-UNIPOLAR CARDIAC PULSE GENERAT is an FDA 510(k)-cleared medical device (K832914) 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 November 13, 1983. Regulation: 8.