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 | Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
| Generic Name | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
| Applicant | Abbott Medical6901 Prestion Roadplano, TX 75024 PMA NumberP140009 Supplement NumberS076 Date Received02/22/2022 Decision Date03/24/2022 Product Codes PJS MHY NHL Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-22 |
| Decision Date | 2022-03-24 |
| PMA | P140009 |
| Supplement | S076 |
| 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 NumberS076 Date Received02/22/2022 Decision Date03/24/2022 Product Codes PJS MHY NHL Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement an Update To The Post-Header Test System Non-Product Software Used During Assembly Of Orion Family (Proclaim SCS, Infinity DBS, Proclaim DRG) Implantable Pulse Generators (IPGs) |
| 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 |