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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceAxium Neurostimulator System
Classification Namedorsal root ganglion stimulator for pain relief
Generic Namedorsal root ganglion stimulator for pain relief
Applicant
Spinal Modulation, Inc
1135 o'brien dr
menlo park, CA 94025
PMA NumberP150004
Date Received01/29/2015
Decision Date02/11/2016
Product Code
PMP[ Registered Establishments with 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 StudyShow Report Schedule and Study Progress
Supplements: S001 S004 
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