|
Device | Axium Neurostimulator System |
Generic Name | Dorsal root ganglion stimulator for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P150004 |
Supplement Number | S023 |
Date Received | 05/30/2018 |
Decision Date | 03/26/2019 |
Product Code |
PMP |
Advisory Committee |
Neurology |
Clinical Trials | NCT02800863
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for Axium Neurostimulator System. The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II*. |