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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:  S004 S008 S009 S005 S001 S002 S007 S006 S010 S020 S025 
S013 S014 S015 S030 S043 S040 S032 S052 S053 S054 S050 S051 
S045 S059 S062 S063 S064 S068 S016 S017 S018 S026 S012 S022 
S019 S023 S024 S031 S041 S042 S035 S036 S037 S038 S039 S033 
S034 S027 S028 S029 S056 S044 S047 S048 S049 S060 S061 S055 
S057 S046 S065 S066 S067 S070 S072 
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