PMA P970003S015
- Device
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S015
- 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
- Approval for a new manufacturing site located at Cyberonics, Inc., 16511 Space Center Blvd., Suite 500, Houston, TX.
Current openFDA PMA Record#
- Device
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S015
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 1999-01-28
- Decision code
- APPR
- Date received
- 1998-12-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a new manufacturing site located at Cyberonics, Inc., 16511 Space Center Blvd., Suite 500, Houston, TX.