510(k) Report

Devices descending from K900461

1 later device reach Opus Model 4021, Vvi, 5MM Unipolar through their predicates, nearest generation first.

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