PMA P970003S020
- Device
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S020
- Product code
- LYJ
- Decision date
- 1999-04-05
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- The 30-Day Notice requested relocation of the Feed Through Welding Equipment fromt he Webster, TX manufacturing facility to the existing Houston, TX (Space Center) manufacturing facility.
Current openFDA PMA Record#
- Device
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S020
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 1999-04-05
- Decision code
- OK30
- Date received
- 1999-03-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-Day Notice requested relocation of the Feed Through Welding Equipment fromt he Webster, TX manufacturing facility to the existing Houston, TX (Space Center) manufacturing facility.