510(k) Report

Devices descending from K952363

1 later device reach Opus Pacemakers (Models 4021, 4033, and 4034) through their predicates, nearest generation first.

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