Axium Neurostimulator System

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Premarket Approval P150004

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.

Pre-market Approval Supplement Details

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.

DeviceAxium Neurostimulator System
Classification NameDorsal Root Ganglion Stimulator For Pain Relief
Generic NameDorsal Root Ganglion Stimulator For Pain Relief
ApplicantAbbott Medical
Date Received2015-01-29
Decision Date2016-02-11
Notice Date2016-03-07
PMAP150004
SupplementS
Product CodePMP
Docket Number16M-0804
Advisory CommitteeNeurology
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Medical 6901 Preston Road plano, TX 75024
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P150004Original Filing
S057 2022-05-23 Real-time Process
S056 2022-02-22 30-day Notice
S055 2022-01-18 30-day Notice
S054 2021-10-22 Real-time Process
S053
S052
S051 2021-07-07 Normal 180 Day Track No User Fee
S050 2021-07-01 30-day Notice
S049
S048 2021-06-15 Special (immediate Track)
S047 2021-05-10 30-day Notice
S046 2021-03-25 30-day Notice
S045
S044
S043 2020-09-09 Normal 180 Day Track
S042 2020-07-27 Real-time Process
S041
S040
S039 2020-05-07 30-day Notice
S038 2020-04-30 30-day Notice
S037
S036 2020-04-06 30-day Notice
S035 2020-04-06 30-day Notice
S034 2019-12-13 30-day Notice
S033
S032 2019-10-21 30-day Notice
S031 2019-07-01 30-day Notice
S030 2019-05-02 Real-time Process
S029
S028 2018-11-08 30-day Notice
S027 2018-09-28 Real-time Process
S026 2018-09-04 Real-time Process
S025 2018-08-20 30-day Notice
S024 2018-06-18 Real-time Process
S023 2018-05-30 Normal 180 Day Track No User Fee
S022 2018-04-20 30-day Notice
S021
S020 2018-02-13 Normal 180 Day Track
S019 2017-12-18 30-day Notice
S018 2017-11-16 30-day Notice
S017 2017-11-15 30-day Notice
S016 2017-11-09 30-day Notice
S015 2017-09-13 30-day Notice
S014 2017-09-11 Real-time Process
S013 2017-08-22 30-day Notice
S012 2017-08-10 30-day Notice
S011
S010 2017-06-02 30-day Notice
S009 2017-04-06 30-day Notice
S008 2017-04-03 Normal 180 Day Track
S007 2017-02-14 Normal 180 Day Track No User Fee
S006 2016-11-07 Normal 180 Day Track
S005 2016-10-05 Normal 180 Day Track No User Fee
S004 2016-07-21 30-day Notice
S003
S002 2016-06-06 Normal 180 Day Track
S001 2016-03-11 Normal 180 Day Track No User Fee

NIH GUDID Devices

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05415067029072 P150004 008

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