Approval for changes to the hospital system guide for the cardiomems hf system to clarify the instructions for powering down the hospital electronics unit (cm3000), and more detailed instructions for the merlin. Net setup and access.
| Device | CARDIOMEMS HF SYSTEM |
| Classification Name | System, Hemodynamic, Implantable |
| Generic Name | System, Hemodynamic, Implantable |
| Applicant | St. Jude Medical |
| Date Received | 2016-10-17 |
| Decision Date | 2016-11-16 |
| PMA | P100045 |
| Supplement | S012 |
| Product Code | MOM |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical 387 Technology Circle Nw suite 500 atlanta, GA 30313 |
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