VNS THERAPY SYSTEM
FDA premarket approval P970003/S083 · decided 2008-05-01
Approval details
- PMA number
- P970003
- Supplement
- S083
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- VNS THERAPY SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2007-05-24
- Decision date
- 2008-05-01
- Days to decision
- 343 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY.
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510(k) clearances by this applicant
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| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
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