PMA P970003S017
- Device
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S017
- Product code
- LYJ
- Decision date
- 1999-01-28
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- The 30-Day Notice requested to bring in-house a seam welding process equivalent to processes performed by subcontractors. The welding process involves welding the can bottom half of the Pulse Generator to a can lid.
Current openFDA PMA Record#
- Device
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S017
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 1999-01-28
- Decision code
- OK30
- Date received
- 1999-01-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-Day Notice requested to bring in-house a seam welding process equivalent to processes performed by subcontractors. The welding process involves welding the can bottom half of the Pulse Generator to a can lid.