VNS Therapy System
FDA premarket approval P970003/S222 · decided 2019-02-14
Approval details
- PMA number
- P970003
- Supplement
- S222
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VNS Therapy System
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2019-01-15
- Decision date
- 2019-02-14
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Approval for the following labeling updates:1) Model 1000 (SN < 100,000) High Impedance Warning - the addition of a warning to the VNS Therapy Physicians Manuals for both Epilepsy and Depression regarding the potential for erroneous high impedance warning messages that can be received in certain Model 1000 Generators (i.e. Serial Number (SN) < 100,000); and2) Model 1000 (SN < 100,000) Package Insert: the creation of a package insert, containing the same warning information described above, that
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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 |
| SMARxT Tubing and Connectors (K233702) | LivaNova USA, Inc. | 2024-08-08 |