PMA P970003S183
- Device
- VNS THERAPY SYSTEM, VNS THERAPY PROGRAMMING SOFTWARE (V11.0.4)
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S183
- Product code
- MUZ
- Decision date
- 2015-10-28
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order 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.
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM, VNS THERAPY PROGRAMMING SOFTWARE (V11.0.4)
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S183
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2015-10-28
- Decision code
- APPR
- Date received
- 2015-07-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.