NEUROCYBERNETIC PROSTHESIS SYSTEM
FDA premarket approval P970003/S034 · decided 2001-06-29
Approval details
- PMA number
- P970003
- Supplement
- S034
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NEUROCYBERNETIC PROSTHESIS SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2001-05-21
- Decision date
- 2001-06-29
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR THE MODEL 101 IN-LINE PULSE GENERATOR (VERSION 2.0), MODEL 302 IN-LINE BIPOLAR LEADS (VERSION 1.0), MODEL 402 IN-LINE TUNNELING TOOL (VERSION 1.0 AND LABELING CHANGES.
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