PMA P970003S224
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S224
- Product code
- LYJ
- Decision date
- 2019-05-22
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Add an alternate hydrogen peroxide (HP) sterilizer (STERIS DLTS-V-S7) to the manufacturing process for the sterilization of all sterile VNS Therapy products including Generators (M102, M102R, M103, M104, M106, M1000, M7103 and M8103), Leads (M302, M303, M304 and M7304), Tunneler (M402), and the Accessory Pack (M502).
Current openFDA PMA Record#
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S224
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2019-05-22
- Decision code
- OK30
- Date received
- 2019-04-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate hydrogen peroxide (HP) sterilizer (STERIS DLTS-V-S7) to the manufacturing process for the sterilization of all sterile VNS Therapy products including Generators (M102, M102R, M103, M104, M106, M1000, M7103 and M8103), Leads (M302, M303, M304 and M7304), Tunneler (M402), and the Accessory Pack (M502).