510(k) Report

Devices descending from K133481

3 later devices reach SJM Confirm Implantable Cardiac Monitor (Icm) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+2K182981Confirm Rx Insertable Cardiac MonitorAbbott20190—
+2K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical20170—