PMA P970003S154
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S154
- Product code
- MUZ
- Decision date
- 2013-02-01
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order 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.
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S154
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2013-02-01
- Decision code
- APPR
- Date received
- 2012-11-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.