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.
| Device | CardioMEMS HF System |
| Generic Name | System, Hemodynamic, Implantable |
| Applicant | St. Jude Medical387 Technology Circle Nwsuite 500atlanta, GA 30313 PMA NumberP100045 Supplement NumberS061 Date Received03/03/2022 Decision Date03/31/2022 Product Code MOM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-03 |
| Decision Date | 2022-03-31 |
| PMA | P100045 |
| Supplement | S061 |
| 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 PMA NumberP100045 Supplement NumberS061 Date Received03/03/2022 Decision Date03/31/2022 Product Code MOM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement alternate, Drop-in Replacement Printed Circuit Board Assembly Components For Use With The CardioMEMS CM3100 Hospital System |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 05414734509299 | P100045 | 000 |
| 05414734509190 | P100045 | 000 |
| 05414734509213 | P100045 | 000 |
| 05414734509251 | P100045 | 000 |
| 05414734509275 | P100045 | 000 |
| 05414734509282 | P100045 | 000 |
| 05414734509268 | P100045 | 000 |
| 05414734509312 | P100045 | 000 |
| 05414734509398 | P100045 | 000 |
| 05414734509909 | P100045 | 000 |
| 05414734509916 | P100045 | 000 |
| 05414734509923 | P100045 | 000 |
| 05414734509978 | P100045 | 000 |
| 05414734510257 | P100045 | 000 |
| 05414734509220 | P100045 | 000 |
| 05414734509206 | P100045 | 000 |
| 05414734509183 | P100045 | 000 |
| 05415067034915 | P100045 | 049 |
| 05415067034731 | P100045 | 049 |
| 05415067034724 | P100045 | 049 |
| 05415067034724 | P100045 | 059 |