PMA P970003S216
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S216
- Product code
- LYJ
- Decision date
- 2018-01-24
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Changes that are being made to the Electrical Test System (ETS) used during the production of the SenTiva Model 1000 Generator and the Model 2000 Programming Wand.
Current openFDA PMA Record#
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S216
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2018-01-24
- Decision code
- OK30
- Date received
- 2017-12-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes that are being made to the Electrical Test System (ETS) used during the production of the SenTiva Model 1000 Generator and the Model 2000 Programming Wand.