PMA P970003S135
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S135
- Product code
- LYJ
- Decision date
- 2011-10-31
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- APPROVAL FOR AN UPGRADE TO THE COMMUNICATION FLASH LOADER (CFL) PORTION OF THE FIRMWARE OF THE DEMIPULSE IMPLANTABLE PULSE GENERATORS, MODEL 103 AND MODEL 104.
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S135
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2011-10-31
- Decision code
- APPR
- Date received
- 2011-09-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN UPGRADE TO THE COMMUNICATION FLASH LOADER (CFL) PORTION OF THE FIRMWARE OF THE DEMIPULSE IMPLANTABLE PULSE GENERATORS, MODEL 103 AND MODEL 104.