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 | Abbott Medical387 Technology Circle, Nwsuite 500atlanta, GA 30313 PMA NumberP100045 Supplement NumberS063 Date Received08/18/2022 Decision Date09/15/2022 Product Code MOM Advisory Committee Cardiovascular Clinical TrialsNCT02279888 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-08-18 |
| Decision Date | 2022-09-15 |
| PMA | P100045 |
| Supplement | S063 |
| Product Code | MOM |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 387 Technology Circle, Nw suite 500 atlanta, GA 30313 PMA NumberP100045 Supplement NumberS063 Date Received08/18/2022 Decision Date09/15/2022 Product Code MOM Advisory Committee Cardiovascular Clinical TrialsNCT02279888 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement approval Of The Protocol For The Post-approval Study (PAS) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P100045/S056. |
| 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 |