510(k) Report

Devices descending from K952364

1 later device reach Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K970072Opus S Model 4121 and 4124 PacemakersEla Medical, Inc.19970—