OPUS S MODEL 4121 AND 4124 PACEMAKERS

OPUS S MODEL 4121 AND 4124 PACEMAKERS is an FDA 510(k)-cleared medical device (K970072) 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 August 28, 1997. Regulation: 8.