OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)

OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) is an FDA 510(k)-cleared medical device (K952364) 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 31, 1995. Regulation: 8.