VNS THERAPY ACCESSORY PACK
FDA premarket approval P970003/S164 · decided 2013-09-23
Approval details
- PMA number
- P970003
- Supplement
- S164
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VNS THERAPY ACCESSORY PACK
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Applicant
- LivaNova USA, Inc.
- Date received
- 2013-06-26
- Decision date
- 2013-09-23
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR A DESIGN CHANGE TO THE IN-LINE TEST RESISTOR THAT IS USED INCONJUNCTION WITH SINGLE PIN PULSE GENERATORS DURING PERIOPERATIVE TROUBLESHOOTING.
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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 |