Approval for the cardiomems hf system, which includes the cm2000 implantable pa sensor/monitor and transvenous catheter delivery system, the cm1000 patient electronics system (gsm), thecm1010 patient electronics system (gsm), and cm3000 hospital electronics system. This device is indicated for wirelessly measuring and monitoring pulmonary artery (pa) pressure and heart rate in new york heart association (nyha) class iii heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P100045 | | Original Filing |
| S064 |
2022-12-09 |
30-day Notice |
| S063 |
2022-08-18 |
Normal 180 Day Track No User Fee |
| S062 |
2022-03-14 |
30-day Notice |
| S061 |
2022-03-03 |
30-day Notice |
| S060 |
2022-02-02 |
30-day Notice |
| S059 | | |
| S058 |
2021-08-17 |
30-day Notice |
| S057 | | |
| S056 | | |
| S055 |
2021-06-04 |
30-day Notice |
| S054 | | |
| S053 | | |
| S052 | | |
| S051 |
2021-03-25 |
30-day Notice |
| 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 |
NIH GUDID Devices