K083828

Substantially Equivalent

SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT

Applicant: Transoma
Product code: MXC
Advisory panel: Cardiovascular
Date received: 2008-12-23
Decision date: 2009-02-11
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

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.