VNS THERAPY SYSTEM
FDA premarket approval P970003/S146 · decided 2013-11-26
Approval details
- PMA number
- P970003
- Supplement
- S146
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- VNS THERAPY SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Applicant
- LivaNova USA, Inc.
- Date received
- 2012-03-08
- Decision date
- 2013-11-26
- Days to decision
- 628 days
- Decision code
- APPR
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- REQUESTED APPROVAL FOR A LABELING UPDATE TO INCLUDE THE RESULTS OF THE D-21 POST APPROVALSTUDY.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
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