VNS THERAPY SYSTEM
FDA premarket approval P970003/S078 · decided 2007-04-12
Approval details
- PMA number
- P970003
- Supplement
- S078
- 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
- 2007-03-27
- Decision date
- 2007-04-12
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR THE ADDITION OF DETAILED INFORMATION CONTAINED IN THE APPROVED TEST TO THE FIGURES PROVIDED IN THE LABELING TO PROVIDE FURTHER CLARIFICATION CONCERNING THE PROPER LEAD IMPLANT TECHNIQUE. ADDITIONALLY, FURTHER DETAILS WERE PROVIDED TO STRESS THE IMPORTANCE OF PROPER STRAIN RELIEF PLACEMENT (I.E. PROPER TIE-DOWN LOCATION AND STRAIN RELIEF BEND).
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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 |