K871915

Substantially Equivalent

MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543

Applicant: Pace Medical
Product code: DTE
Advisory panel: Cardiovascular
Date received: 1987-05-18
Decision date: 1987-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Adverse events under product code DTE

product code DTE

Death: 18
Injury: 247
Malfunction: 4,603
Total: 4,868

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.