OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004

OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004 is an FDA 510(k)-cleared medical device (K882476) manufactured by Ela Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on September 11, 1988. Regulation: 8.