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.
| Device | Deep Brain Stimulation (DBS) System |
| Generic Name | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
| Applicant | Abbott Medical6901 Prestion Roadplano, TX 75024 PMA NumberP140009 Supplement NumberS079 Date Received09/21/2022 Decision Date10/17/2022 Product Code MHY Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-21 |
| Decision Date | 2022-10-17 |
| PMA | P140009 |
| Supplement | S079 |
| 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 PMA NumberP140009 Supplement NumberS079 Date Received09/21/2022 Decision Date10/17/2022 Product Code MHY Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Qualify An Additional Manufacturing Site In Bethel, Connecticut To Manufacture Nitinol Tubes, Which Will Be Used In The Manufacture Of The DBS Extensions |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 05415067020697 | P140009 | 001 |
| 05415067020673 | P140009 | 001 |
| 05415067020680 | P140009 | 001 |
| 05415067020659 | P140009 | 001 |
| 05415067020703 | P140009 | 001 |
| 05415067020857 | P140009 | 001 |
| 05415067020864 | P140009 | 001 |
| 05415067023667 | P140009 | 001 |
| 05415067023988 | P140009 | 001 |
| 05415067024015 | P140009 | 001 |
| 05415067020642 | P140009 | 001 |
| 05415067020635 | P140009 | 001 |
| 05415067020307 | P140009 | 001 |
| 05415067020277 | P140009 | 001 |
| 05415067020260 | P140009 | 001 |
| 05415067020253 | P140009 | 001 |
| 05415067020246 | P140009 | 001 |
| 05415067020666 | P140009 | 001 |
| 05415067030351 | P140009 | 037 |
| 05415067030344 | P140009 | 037 |
| 05415067030337 | P140009 | 037 |
| 05415067030320 | P140009 | 037 |
| 05415067030313 | P140009 | 037 |
| 05415067030306 | P140009 | 037 |
| 05415067030023 | P140009 | 037 |
| 05415067030016 | P140009 | 037 |
| 05415067047670 | P140009 | 087 |
| 05415067047663 | P140009 | 087 |