VNS THERAPY PULSE GENERATORS
FDA premarket approval P970003/S081 · decided 2007-05-14
Approval details
- PMA number
- P970003
- Supplement
- S081
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VNS THERAPY PULSE GENERATORS
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2007-04-30
- Decision date
- 2007-05-14
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL TO ADD ADDITIONAL PRECAUTIONARY INFORMATION TO THE MODEL 300 LEAD PHYSICIAN?S MANUAL AS AN ERRATA SHEET AND TO REVISE THE MODEL 102, 102R, 302 AND 303 VNS THERAPY PHYSICIAN?S MANUAL MODULE ENTITLED ?INTRODUCTION TO THE VNS THERAPY (SYSTEM INDICATIONS, CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS).?
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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 |