VNS THERAPY PERENNIAFLEX
FDA premarket approval P970003/S100 · decided 2008-12-19
Approval details
- PMA number
- P970003
- Supplement
- S100
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VNS THERAPY PERENNIAFLEX
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2008-07-24
- Decision date
- 2008-12-19
- Days to decision
- 148 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR THE FOLLOWING MINOR MODIFICATIONS TO THE APPROVEDMODEL 303 STIMULATION LEAD (THE NEW MODEL TO BE REFERRED TO AS "304"):1) CHANGING THE COIL MATERIAL TO ONE WITH A LOWER TITANIUM TOLERANCE (< 0.01%) TO IMPROVEFATIGUE RESISTANCE;2) CHANGING THE INSULATING MATERIAL TO ONE THAT IS SIMILAR, BUT WITH IMPROVED FATIGUE ANDABRASION RESISTANCE;3) ADDING A CONTROLLED FILLET TO THE ELECTRODE BIFURCATION TO IMPROVE FATIGUE RESISTANCE, AND4) ADDING AN INTERMEDIATE ELECTRODE SIZE (2.5 MM) THAT ALS
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
| RAP Femoral Venous Cannulae (K250283) | LivaNova USA, Inc. | 2025-07-10 |
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