Brio Neurostimulation System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Premarket Approval P140009 S051

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).

DeviceBrio Neurostimulation System
Classification NameStimulator, Electrical, Implanted, For Parkinsonian Tremor
Generic NameStimulator, Electrical, Implanted, For Parkinsonian Tremor
ApplicantAbbott Medical
Date Received2019-10-21
Decision Date2019-11-19
PMAP140009
SupplementS051
Product CodeMHY
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Medical 6901 Prestion Road plano, TX 75024

Supplemental Filings

Supplement NumberDateSupplement Type
P140009Original Filing
S051 2019-10-21 30-day Notice
S050 2019-08-09 Special (immediate Track)
S049
S048 2019-07-01 30-day Notice
S047 2019-05-07 Normal 180 Day Track No User Fee
S046
S045 2019-02-01 30-day Notice
S044 2018-12-17 30-day Notice
S043 2018-11-08 30-day Notice
S042 2018-10-19 30-day Notice
S041 2018-10-18 Special (immediate Track)
S040 2018-09-06 30-day Notice
S039
S038 2018-05-04 135 Review Track For 30-day Notice
S037 2018-02-13 Normal 180 Day Track
S036 2018-02-02 135 Review Track For 30-day Notice
S035 2017-12-18 30-day Notice
S034 2017-12-15 Real-time Process
S033 2017-12-15 30-day Notice
S032 2017-11-16 30-day Notice
S031 2017-11-13 30-day Notice
S030 2017-09-11 Real-time Process
S029 2017-09-08 30-day Notice
S028 2017-08-10 30-day Notice
S027 2017-07-28 Normal 180 Day Track No User Fee
S026
S025 2017-06-26 30-day Notice
S024 2017-06-02 30-day Notice
S023 2017-02-14 Real-time Process
S022 2016-11-07 Normal 180 Day Track
S021 2016-11-01 30-day Notice
S020 2016-10-11 Real-time Process
S019 2016-07-11 Real-time Process
S018
S017 2016-06-22 Real-time Process
S016 2016-06-13 30-day Notice
S015 2016-06-06 Normal 180 Day Track
S014 2016-04-28 30-day Notice
S013 2016-03-21 30-day Notice
S012 2016-02-02 30-day Notice
S011 2016-01-27 30-day Notice
S010 2015-12-11 Normal 180 Day Track
S009 2015-11-09 30-day Notice
S008 2015-11-06 30-day Notice
S007 2015-10-08 30-day Notice
S006 2015-10-07 30-day Notice
S005 2015-09-21 Real-time Process
S004 2015-08-21 Normal 180 Day Track No User Fee
S003 2015-08-14 30-day Notice
S002 2015-08-04 Real-time Process
S001 2015-07-02 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
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05415067020697 P140009 001
05415067020680 P140009 001
05415067020673 P140009 001
05415067020666 P140009 001
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05415067020642 P140009 001
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05415067020277 P140009 001
05415067020260 P140009 001
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05415067030344 P140009 037
05415067030337 P140009 037
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05415067030313 P140009 037
05415067030306 P140009 037
05415067030023 P140009 037
05415067030016 P140009 037
05415067030351 P140009 037

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