PMA P970003S199
- Device
- PULSE MODEL 102, DEMIPULSE MODEL 103, ASPIREHC MODEL 105, ASPIRESR MODEL 106 GENERATOR.
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S199
- Product code
- LYJ
- Decision date
- 2016-06-08
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Use of a new resistance welder during the spot welding of anchor tabs onto Model 102, 103, 105 and 106 generator-cans of the VNS Therapy Systems.
Current openFDA PMA Record#
- Device
- PULSE MODEL 102, DEMIPULSE MODEL 103, ASPIREHC MODEL 105, ASPIRESR MODEL 106 GENERATOR.
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S199
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2016-06-08
- Decision code
- OK30
- Date received
- 2016-05-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of a new resistance welder during the spot welding of anchor tabs onto Model 102, 103, 105 and 106 generator-cans of the VNS Therapy Systems.