VNS THERAPY DEMIPULSE & DEMIPULSE DUO GENERATORS
FDA premarket approval P970003/S098 · decided 2008-04-03
Approval details
- PMA number
- P970003
- Supplement
- S098
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VNS THERAPY DEMIPULSE & DEMIPULSE DUO GENERATORS
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2008-02-04
- Decision date
- 2008-04-03
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR TWO CHANGES TO HE PULSE GENERATOR SOFTWARE TO ELIMINATE A RARE TIMING CONDITION THAT MAY CAUSE THE SOFTWARE WATCHDOG TO, AT THE END OF A MAGNET-INITIATED BURST, REPORT AN ERROR EVEN THOUGH NO SUCH ERROR OCCURRED.
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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 |