PULSE GENERATORS MODELS 657 & 677

PULSE GENERATORS MODELS 657 & 677 is an FDA 510(k)-cleared medical device (K800387) manufactured by Siemens Elema AB. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on May 1, 1980. Regulation: 8.