VNS THERAPY PULSE GENERATOR, LEAD AND PATIENT KIT
FDA premarket approval P970003/S063 · decided 2006-06-29
Approval details
- PMA number
- P970003
- Supplement
- S063
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VNS THERAPY PULSE GENERATOR, LEAD AND PATIENT KIT
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2006-01-27
- Decision date
- 2006-06-29
- Days to decision
- 153 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR LABELING HARMONIZATION AND MODULARIZATION FOR PHYSICIAN, PULSE GENERATOR, LEAD AND PATIENT KIT LABELING.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |