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).
Device | Brio Neurostimulation System |
Classification Name | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Generic Name | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Applicant | Abbott Medical |
Date Received | 2019-10-21 |
Decision Date | 2019-11-19 |
PMA | P140009 |
Supplement | S051 |
Product Code | MHY |
Advisory Committee | Neurology |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Abbott Medical 6901 Prestion Road plano, TX 75024 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P140009 | | Original 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