K090907

Substantially Equivalent

PENTA LEAD KITS, MODELS: 3227-3234

Applicant: Advanced Neuromodulation Systems
Product code: GZB
Advisory panel: Neurology
Date received: 2009-04-01
Decision date: 2009-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Adverse events under product code GZB

product code GZB

Death: 4
Injury: 1,879
Other: 2
Total: 1,885

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.