PMA P970003S179
- Device
- PULSE GENERATOR-MODEL102, PULSE DUO GENERATOR-MODEL 102R
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S179
- Product code
- LYJ
- Decision date
- 2015-08-21
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- APPROVAL FOR THE INTRODUCTION OF AN ALTERNATE MICROPROCESSOR, MANUFACTURED BY A DIFFERENT VENDOR, FOR THE MODEL 102/102R PULSE GENERATORS USED IN THE VNS THERAPY SYSTEM.
Current openFDA PMA Record#
- Device
- PULSE GENERATOR-MODEL102, PULSE DUO GENERATOR-MODEL 102R
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S179
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2015-08-21
- Decision code
- APPR
- Date received
- 2015-05-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE INTRODUCTION OF AN ALTERNATE MICROPROCESSOR, MANUFACTURED BY A DIFFERENT VENDOR, FOR THE MODEL 102/102R PULSE GENERATORS USED IN THE VNS THERAPY SYSTEM.