NEUROCYBERNETIC PROTHESIS (NCP) SYSTEM
FDA premarket approval P970003/S047 · decided 2003-08-14
Approval details
- PMA number
- P970003
- Supplement
- S047
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NEUROCYBERNETIC PROTHESIS (NCP) SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2003-06-20
- Decision date
- 2003-08-14
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- 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.
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