PMA P970003S070
- Device
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S070
- Product code
- LYJ
- Decision date
- 2006-09-05
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order 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.
Current openFDA PMA Record#
- Device
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S070
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2006-09-05
- Decision code
- APPR
- Date received
- 2006-07-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.