VNS THERAPY SYSTEM
FDA premarket approval P970003/S050 · decided 2005-07-15
Approval details
- PMA number
- P970003
- Supplement
- S050
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VNS THERAPY SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Applicant
- LivaNova USA, Inc.
- Date received
- 2003-10-27
- Decision date
- 2005-07-15
- Days to decision
- 627 days
- Decision code
- APPR
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- Yes
- Location
- Houston, TX
- Statement
- APPROVAL FOR THE VNS THERAPY SYSTEM. THE DEVICE IS INDICATED FOR THE ADJUNCTIVE LONG-TERM TREATMENT OF CHRONIC OR RECURRENT DEPRESSION FOR PATIENTS 18 YEARS OF AGE OR OLDER WHO ARE EXPERIENCING A MAJOR DEPRESSIVE EPISODE AND HAVE NOT HAD AN ADEQUATE RESPONSE TO FOUR OR MORE ADEQUATE ANTIDEPRESSANT TREATMENTS.
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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 |