PMA P970003S047
- Device
- NEUROCYBERNETIC PROTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S047
- Product code
- LYJ
- Decision date
- 2003-08-14
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- APPROVAL FOR THE NEUROCYBERNETIC PROTHESIS (NCP) SYSTEM MODEL 102R GENERATOR, HUMAN FACTORS IMPROVEMENTS TO THE MODEL 102 GENERATOR AND LABELING CHANGES TO THE MODEL 302 LEAD WHICH ARE INDICATED FOR USE AS AN ADJUNCTIVE THERAPY IN REDUCING THE FREQUENCY OF SEIZURES THAT ARE REFRACTORY TO ANTIEPILEPTIC MEDICATIONS.
Current openFDA PMA Record#
- Device
- NEUROCYBERNETIC PROTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S047
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2003-08-14
- Decision code
- APPR
- Date received
- 2003-06-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE NEUROCYBERNETIC PROTHESIS (NCP) SYSTEM MODEL 102R GENERATOR, HUMAN FACTORS IMPROVEMENTS TO THE MODEL 102 GENERATOR AND LABELING CHANGES TO THE MODEL 302 LEAD WHICH ARE INDICATED FOR USE AS AN ADJUNCTIVE THERAPY IN REDUCING THE FREQUENCY OF SEIZURES THAT ARE REFRACTORY TO ANTIEPILEPTIC MEDICATIONS.