PMA P970003S188
- Device
- PULSE/PULSE DUO GENERATOR-MODEL 102/102R
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S188
- Product code
- MUZ
- Decision date
- 2016-02-19
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- Approval for labeling changes being made to the Model 102/102R Technical Information Chapter of the VNS Therapy Physician’s Manual involving the addition/correction of information concerning generator performance exceptions.
Current openFDA PMA Record#
- Device
- PULSE/PULSE DUO GENERATOR-MODEL 102/102R
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S188
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2016-02-19
- Decision code
- APPR
- Date received
- 2015-11-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for labeling changes being made to the Model 102/102R Technical Information Chapter of the VNS Therapy Physician’s Manual involving the addition/correction of information concerning generator performance exceptions.