MODIFICATION TO RENEW LEAD EXTENSION— 510(k) K032751

Substantially Equivalent

Advanced Neuromodulation Systems

FDA 510(k) clearance K032751 for MODIFICATION TO RENEW LEAD EXTENSION, Substantially Equivalent on 2003-10-06. Applicant: Advanced Neuromodulation Systems.

Clearance details

Applicant: Advanced Neuromodulation Systems
Product code: Code GZB
Advisory panel: Neurology
Date received: 2003-09-05
Decision date: 2003-10-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Plano, TX, US

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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.