PMA P970003S103
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S103
- Product code
- LYJ
- Decision date
- 2008-12-19
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- APPROVAL FOR THE ADDITION OF A SOFTWARE ACCESSORY/TOOL REFERRED TO AS THE ¿GENERATOR FIELD UPGRADER¿ (GFU). THE GFU IS DESIGNED TO BE USED TO UPGRADE SOFTWARE IN THE DEMIPULSE, MODEL 103 AND DEMIPULSE DUO, MODEL 104 PULSE GENERATORS TO EITHER ENHANCE PRE-EXISTING FEATURES OR TO RESOLVE SOFTWARE ANOMALIES.
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S103
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2008-12-19
- Decision code
- APPR
- Date received
- 2008-10-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF A SOFTWARE ACCESSORY/TOOL REFERRED TO AS THE ¿GENERATOR FIELD UPGRADER¿ (GFU). THE GFU IS DESIGNED TO BE USED TO UPGRADE SOFTWARE IN THE DEMIPULSE, MODEL 103 AND DEMIPULSE DUO, MODEL 104 PULSE GENERATORS TO EITHER ENHANCE PRE-EXISTING FEATURES OR TO RESOLVE SOFTWARE ANOMALIES.