VNS THERAPY SYSTEM, VNS THERAPY PROGRAMMING SOFTWARE (V11.0.4)
FDA premarket approval P970003/S183 · decided 2015-10-28
Approval details
- PMA number
- P970003
- Supplement
- S183
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VNS THERAPY SYSTEM, VNS THERAPY PROGRAMMING SOFTWARE (V11.0.4)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Applicant
- LivaNova USA, Inc.
- Date received
- 2015-07-29
- Decision date
- 2015-10-28
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR THE INTRODUCTION OF THE MOTION CL910 AND MINOR MODIFICATIONS AND ENHANCEMENTS TO THE VNS THERAPY PROGRAMMING SOFTWARE MODEL 250 VERSION 11.0.4.
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