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.
Rework the lcd screens from the cardiomems i3 patient electronic system (pes) returns inventory and use them in the new pes manufacturing builds
| Device | CardioMEMS HF System |
| Generic Name | System, Hemodynamic, Implantable |
| Applicant | St. Jude Medical |
| Date Received | 2020-12-03 |
| Decision Date | 2020-12-22 |
| PMA | P100045 |
| Supplement | S046 |
| Product Code | MOM |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical 387 Technology Circle Nw suite 500 atlanta, GA 30313 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100045 | Original Filing | |
| S046 | 2020-12-03 | 30-day Notice |
| S045 | 2020-07-15 | 30-day Notice |
| S044 | 2020-06-29 | 30-day Notice |
| S043 | ||
| S042 | 2020-03-18 | 30-day Notice |
| S041 | 2019-11-07 | Real-time Process |
| S040 | 2019-10-18 | 30-day Notice |
| S039 | 2019-03-13 | 30-day Notice |
| S038 | 2019-02-19 | 30-day Notice |
| S037 | 2019-01-31 | 30-day Notice |
| S036 | 2019-01-08 | Real-time Process |
| S035 | 2018-10-29 | Real-time Process |
| S034 | 2018-10-09 | Real-time Process |
| S033 | 2018-10-09 | 30-day Notice |
| S032 | 2018-09-24 | 30-day Notice |
| S031 | 2018-07-20 | 30-day Notice |
| S030 | 2018-06-29 | 30-day Notice |
| S029 | 2018-06-12 | 30-day Notice |
| S028 | 2018-01-29 | 30-day Notice |
| S027 | ||
| S026 | ||
| S025 | 2017-10-12 | Real-time Process |
| S024 | 2017-08-10 | 30-day Notice |
| S023 | 2017-07-17 | Real-time Process |
| S022 | 2017-07-12 | Normal 180 Day Track No User Fee |
| S021 | ||
| S020 | 2017-05-19 | 30-day Notice |
| S019 | 2017-01-10 | 135 Review Track For 30-day Notice |
| S018 | 2016-12-15 | Normal 180 Day Track No User Fee |
| S017 | 2016-11-23 | 135 Review Track For 30-day Notice |
| S016 | 2016-11-22 | 30-day Notice |
| S015 | 2016-11-18 | 135 Review Track For 30-day Notice |
| S014 | 2016-11-17 | Real-time Process |
| S013 | 2016-10-31 | 30-day Notice |
| S012 | 2016-10-17 | Special (immediate Track) |
| S011 | 2016-09-30 | Special (immediate Track) |
| S010 | 2016-08-01 | 30-day Notice |
| S009 | 2016-04-26 | Real-time Process |
| S008 | 2016-03-15 | Normal 180 Day Track No User Fee |
| S007 | 2015-09-04 | Real-time Process |
| S006 | 2015-08-21 | Normal 180 Day Track No User Fee |
| S005 | 2015-04-28 | 30-day Notice |
| S004 | 2015-02-04 | Real-time Process |
| S003 | ||
| S002 | 2014-11-26 | Normal 180 Day Track |
| S001 | 2014-06-30 | Normal 180 Day Track No User Fee |