VNS THERAPY SYSTEM
FDA premarket approval P970003/S166 · decided 2014-05-09
Approval details
- PMA number
- P970003
- Supplement
- S166
- Supplement type
- Normal 180 Day 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
- 2013-11-01
- Decision date
- 2014-05-09
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR LABELING THAT DESCRIBES THE CONDITIONS UNDER WHICH MAGNETIC RESONANCE IMAGING (MRI) CAN BE USED WHEN RESIDUAL VNS LEADS OR LEAD FRAGMENTS (ABANDONED LEADS) REMAIN IN THE BODY.
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510(k) clearances by this applicant
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|---|---|---|
| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
| RAP Femoral Venous Cannulae (K250283) | LivaNova USA, Inc. | 2025-07-10 |
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