PMA P970003S214
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S214
- Product code
- LYJ
- Decision date
- 2017-12-27
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Change to the Leads Manufacturing Process to add the following two (2) processes on all commercially available Lead Models (302/303/304):1) Additional use of the currently approved primer; proposed application to the Suture and along the exposed edge of the Electrode; and2) Implementation of a Protection Aid to encapsulate the Lead Helicals, protecting them from Ribbon Damage during further processing steps. This will be removed at the end of the Lead Final assembly.
Current openFDA PMA Record#
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S214
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2017-12-27
- Decision code
- OK30
- Date received
- 2017-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the Leads Manufacturing Process to add the following two (2) processes on all commercially available Lead Models (302/303/304):1) Additional use of the currently approved primer; proposed application to the Suture and along the exposed edge of the Electrode; and2) Implementation of a Protection Aid to encapsulate the Lead Helicals, protecting them from Ribbon Damage during further processing steps. This will be removed at the end of the Lead Final assembly.