PMA P970003S204
- Device
- ASPIRESR MODEL 106 GENERATOR
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S204
- Product code
- LYJ
- Decision date
- 2016-09-09
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Implementation of new electrical testing for the Model 106 Generator used in the VNS Therapy System, with additional minor test software corrections and improvements.
Current openFDA PMA Record#
- Device
- ASPIRESR MODEL 106 GENERATOR
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S204
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2016-09-09
- Decision code
- OK30
- Date received
- 2016-08-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of new electrical testing for the Model 106 Generator used in the VNS Therapy System, with additional minor test software corrections and improvements.