PMA P970003S208
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S208
- Product code
- LYJ
- Decision date
- 2017-01-18
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Update that is being made to the X-Ray inspection criteria for the presence of solders under the Application Specific Integrated Circuit (ASIC) of the Model 103/104 and Model 105/106 Generator Printed Circuit Board Assemblies (PCBA).
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S208
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2017-01-18
- Decision code
- OK30
- Date received
- 2016-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update that is being made to the X-Ray inspection criteria for the presence of solders under the Application Specific Integrated Circuit (ASIC) of the Model 103/104 and Model 105/106 Generator Printed Circuit Board Assemblies (PCBA).