Demipulse Generator; Demipulse Duo Generator, AspireSR Generator, SenTiva Generator; SenTiva Duo Generator, Symmetr
FDA premarket approval P970003/S238 · decided 2023-02-07
Approval details
- PMA number
- P970003
- Supplement
- S238
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Demipulse Generator; Demipulse Duo Generator, AspireSR Generator, SenTiva Generator; SenTiva Duo Generator, Symmetr
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2023-01-09
- Decision date
- 2023-02-07
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Introduce a new resistance welding system and associated parameter changes utilized in the production of the VNS Therapy System Implantable Pulse Generators.
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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 |