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.
Approval for a replacement liquid crystal display (lcd) in the patient electronics system.
| Device | CardioMEMS HF System |
| Generic Name | System, Hemodynamic, Implantable |
| Applicant | St. Jude Medical |
| Date Received | 2020-12-15 |
| Decision Date | 2021-03-12 |
| PMA | P100045 |
| Supplement | S047 |
| Product Code | MOM |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 | |
| S050 | 2021-03-09 | Normal 180 Day Track No User Fee |
| S049 | ||
| S048 | 2021-02-10 | 30-day Notice |
| S047 | 2020-12-15 | Real-time Process |
| 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 |