VNS Therapy System
FDA premarket approval P970003/S224 · decided 2019-05-22
Approval details
- PMA number
- P970003
- Supplement
- S224
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VNS Therapy System
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2019-04-24
- Decision date
- 2019-05-22
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Add an alternate hydrogen peroxide (HP) sterilizer (STERIS DLTS-V-S7) to the manufacturing process for the sterilization of all sterile VNS Therapy products including Generators (M102, M102R, M103, M104, M106, M1000, M7103 and M8103), Leads (M302, M303, M304 and M7304), Tunneler (M402), and the Accessory Pack (M502).
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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 |