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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 |
Date Received | 01/29/2015 |
Decision Date | 02/11/2016 |
Product Code |
PMP |
Docket Number | 16M-0804 |
Notice Date | 03/07/2016 |
Advisory Committee |
Neurology |
Clinical Trials | NCT01923285
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Axium Spinal Modulation Neurostimulator System. This device 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**. * Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug classes and continued their pharmacologic therapy during the clinical study. ** Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
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