NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
FDA premarket approval P970003/S070 · decided 2006-09-05
Approval details
- PMA number
- P970003
- Supplement
- S070
- 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
- 2006-07-17
- Decision date
- 2006-09-05
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR A CHANGE FROM ADDING A STRAIN RELIEF GROMMET TO THE SERIAL DATA CABLE OF THE MODEL 201 PROGRAMMING WAND DURING FINAL ASSEMBLY TO MOLDING AN IMPROVED STRAIN RELIEF ONTO THE SERIAL DATA CABLE DURING ITS MANUFACTURE AND CHANGES TO THE TIE-DOWN USED IN THE MODEL 302 LEAD, THE MODEL 303 LEAD, AND THE MODEL 502 ACCESSORY PACK.
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