PMA P970003S201
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S201
- Product code
- LYJ
- Decision date
- 2016-07-29
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Removal of the bead blast process from the standard final generator production process and retaining it as an optional process for processing generator cans that do not meet visual acceptance criteria.
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S201
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2016-07-29
- Decision code
- OK30
- Date received
- 2016-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of the bead blast process from the standard final generator production process and retaining it as an optional process for processing generator cans that do not meet visual acceptance criteria.