PMA P970003S110
- Device
- VNS THERAPY SYSTEM PULSE GENERATOR CLEANING PROCESS CHANGE
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S110
- Product code
- LYJ
- Decision date
- 2010-11-05
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- APPROVAL TO CHANGE THE GENERATOR CLEANING PROCESS.
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM PULSE GENERATOR CLEANING PROCESS CHANGE
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S110
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2010-11-05
- Decision code
- APPR
- Date received
- 2010-05-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO CHANGE THE GENERATOR CLEANING PROCESS.