PROLITH MODEL 21S CARDIAC PULSE GEN.

PROLITH MODEL 21S CARDIAC PULSE GEN. is an FDA 510(k)-cleared medical device (K770212) 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 March 8, 1977. Regulation: 8.