SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)— 510(k) K133481

Substantially Equivalent

St. Jude Medical, Inc.

FDA 510(k) clearance K133481 for SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM), Substantially Equivalent on 2014-05-28. Applicant: St. Jude Medical, Inc..

Clearance details

Applicant: St. Jude Medical, Inc.
Product code: Code MXC
Advisory panel: Cardiovascular
Date received: 2013-11-13
Decision date: 2014-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MXC

product code MXC

Death: 4
Injury: 758
Malfunction: 5,066
Total: 5,828

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.