PMA P970003S039
- Device
- NEUROCYBERNETIC PROSTHESES(NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S039
- Product code
- LYJ
- Decision date
- 2002-06-18
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 402 TUNNELING TOOL (VERSION 1), RESULTING IN THE NEW VNS THERAPY TUNNELER, MODEL 402 (VERSION 2), AND MODIFICATIONS TO THE EXISTING MODEL 500 ACCESSORY PACK, RESULTING IN THE NEW VNS THERAPY ACCESSORY PACK, MODEL 502.
Current openFDA PMA Record#
- Device
- NEUROCYBERNETIC PROSTHESES(NCP) SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S039
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2002-06-18
- Decision code
- APPR
- Date received
- 2002-04-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 402 TUNNELING TOOL (VERSION 1), RESULTING IN THE NEW VNS THERAPY TUNNELER, MODEL 402 (VERSION 2), AND MODIFICATIONS TO THE EXISTING MODEL 500 ACCESSORY PACK, RESULTING IN THE NEW VNS THERAPY ACCESSORY PACK, MODEL 502.