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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAxium Neurostimulator System
Generic Namedorsal root ganglion stimulator for pain relief
ApplicantAbbott Medical
6901 preston road
plano, TX 75024
PMA NumberP150004
Date Received01/29/2015
Decision Date02/11/2016
Product Code PMP 
Docket Number 16M-0804
Notice Date 03/07/2016
Advisory Committee Neurology
Clinical TrialsNCT01923285
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S004 S005 S006 S007 S008 S009 S010 S012 S013 
S014 S015 S016 S017 S018 S019 S020 S022 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 
S051 S053 S054 S055 S056 S057 
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