VNS Therapy System
FDA premarket approval P970003/S214 · decided 2017-12-27
Approval details
- PMA number
- P970003
- Supplement
- S214
- 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
- 2017-11-20
- Decision date
- 2017-12-27
- Days to decision
- 37 days
- Decision code
- OK30
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Change to the Leads Manufacturing Process to add the following two (2) processes on all commercially available Lead Models (302/303/304):1) Additional use of the currently approved primer; proposed application to the Suture and along the exposed edge of the Electrode; and2) Implementation of a Protection Aid to encapsulate the Lead Helicals, protecting them from Ribbon Damage during further processing steps. This will be removed at the end of the Lead Final assembly.
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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 |