Axium Neurostimulator System

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Premarket Approval P150004 S032

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Changes in the viable air sampling method and a corresponding change to the action and alert limits for the airborne microbes in the controlled access environments(cae).

DeviceAxium Neurostimulator System
Classification NameDorsal Root Ganglion Stimulator For Pain Relief
Generic NameDorsal Root Ganglion Stimulator For Pain Relief
ApplicantAbbott Medical
Date Received2019-10-21
Decision Date2019-11-19
PMAP150004
SupplementS032
Product CodePMP
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Medical 6901 Preston Road plano, TX 75024

Supplemental Filings

Supplement NumberDateSupplement Type
P150004Original Filing
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

Device IDPMASupp
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05415067029072 P150004 008

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