Alternate manufacturing location for the smt level assemblies used in the manufacturing of the implantable pulse generators (ipgs) and the external accessories for the spinal cord stimulation and deep brain stimulation systems.
| Device | BRIO IMPLANTABLE PULSE GENERATORS (IPGS) |
| Classification Name | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
| Generic Name | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
| Applicant | Abbott Medical |
| Date Received | 2016-02-02 |
| Decision Date | 2016-03-03 |
| PMA | P140009 |
| Supplement | S012 |
| 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 |
| S080 |
2022-09-29 |
30-day Notice |
| S079 |
2022-09-21 |
30-day Notice |
| S078 |
2022-06-02 |
30-day Notice |
| S077 | | |
| S076 |
2022-02-22 |
30-day Notice |
| S075 |
2022-01-18 |
30-day Notice |
| S074 |
2021-10-22 |
Real-time Process |
| S073 | | |
| S072 |
2021-07-01 |
30-day Notice |
| S071 | | |
| S070 |
2021-06-15 |
Special (immediate Track) |
| S069 |
2021-05-10 |
30-day Notice |
| S068 |
2021-03-25 |
30-day Notice |
| S067 | | |
| S066 |
2021-02-08 |
30-day Notice |
| S065 |
2020-10-28 |
135 Review Track For 30-day Notice |
| S064 |
2020-09-09 |
Normal 180 Day Track |
| S063 |
2020-07-27 |
Real-time Process |
| S062 | | |
| S061 |
2020-07-13 |
Special (immediate Track) |
| S060 |
2020-05-07 |
30-day Notice |
| S059 |
2020-04-30 |
30-day Notice |
| S058 | | |
| S057 |
2020-04-06 |
30-day Notice |
| S056 |
2020-04-06 |
30-day Notice |
| S055 |
2020-02-03 |
30-day Notice |
| S054 |
2019-12-13 |
30-day Notice |
| S053 | | |
| S052 | | |
| 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