K042708

Substantially Equivalent

ERA 3000 PACING SYSTEM ANALYZER

Applicant: Biotronik, Inc.
Product code: DTE
Advisory panel: Cardiovascular
Date received: 2004-09-30
Decision date: 2004-10-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Lake Oswego, OR, 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.