PMA P970003S042
- Device
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S042
- Product code
- LYJ
- Decision date
- 2002-07-29
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- APPROVAL FOR MINOR LABELING MODIFICATIONS TO THE EXISTING MODEL 100/101 NCP PULSE GENERATOR PHYSICIAN'S MANUAL.
Current openFDA PMA Record#
- Device
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S042
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2002-07-29
- Decision code
- APPR
- Date received
- 2002-05-01
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MINOR LABELING MODIFICATIONS TO THE EXISTING MODEL 100/101 NCP PULSE GENERATOR PHYSICIAN'S MANUAL.