|
Device | EonC and Eon Mini Neurostimulation System |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S135 |
Date Received | 09/12/2017 |
Decision Date | 12/09/2017 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for enabling the BurstDR™ stimulation feature on the already-implanted Eon family devices (two models: EonC and Eon Mini) for a short evaluation period (30 days). |