NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
FDA premarket approval P970003/S038 · decided 2002-03-28
Approval details
- PMA number
- P970003
- Supplement
- S038
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2002-02-08
- Decision date
- 2002-03-28
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 250 PROGRAMMING SOFTWARE, RESULTING IN NEW VERSIONS 4.6 AND 6.1.
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