LAMITRODE S-SERIES (S4 AND S8) LEADS— 510(k) K022222
Substantially EquivalentAdvanced Neuromodulation System,Inc
FDA 510(k) clearance K022222 for LAMITRODE S-SERIES (S4 AND S8) LEADS, Substantially Equivalent on 2002-08-08. Applicant: Advanced Neuromodulation System,Inc.
Clearance details
- Applicant
- Advanced Neuromodulation System,Inc
- Product code
- Code GZB
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- 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, through . 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.