Approval for updates to the temperature sensitivity manufacturing process
| Device | CardioMEMS HF System |
| Generic Name | System, Hemodynamic, Implantable |
| Applicant | St. Jude Medical |
| Date Received | 2021-08-17 |
| Decision Date | 2021-09-16 |
| PMA | P100045 |
| Supplement | S058 |
| 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 |
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