VNS THERAPY SYSTEM
FDA premarket approval P970003/S111 · decided 2010-08-04
Approval details
- PMA number
- P970003
- Supplement
- S111
- 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
- 2010-06-22
- Decision date
- 2010-08-04
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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