VNS THERAPY SYSTEM
FDA premarket approval P970003/S154 · decided 2013-02-01
Approval details
- PMA number
- P970003
- Supplement
- S154
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VNS THERAPY SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Applicant
- LivaNova USA, Inc.
- Date received
- 2012-11-06
- Decision date
- 2013-02-01
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR AN UPGRADE OF THE PROGRAMMING SOFTWARE TO VERSION 10.0, A NEW PROGRAMMING COMPUTER AND CORRESPONDING ADAPTER CABLE, AND REVISION OF THE HIGH IMPEDANCE THRESHOLD.
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