VNS THERAPY SYSTEM
FDA premarket approval P970003/S174 · decided 2015-06-04
Approval details
- PMA number
- P970003
- Supplement
- S174
- 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 (depression)
- Applicant
- LivaNova USA, Inc.
- Date received
- 2014-11-17
- Decision date
- 2015-06-04
- Days to decision
- 199 days
- Decision code
- APPR
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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