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 PA Sensor and Delivery System |
| Generic Name | System, Hemodynamic, Implantable |
| Applicant | St. Jude Medical387 Technology Circle Nwsuite 500atlanta, GA 30313 PMA NumberP100045 Supplement NumberS062 Date Received03/14/2022 Decision Date04/11/2022 Product Code MOM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-14 |
| Decision Date | 2022-04-11 |
| PMA | P100045 |
| Supplement | S062 |
| 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 NumberS062 Date Received03/14/2022 Decision Date04/11/2022 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 to Implement An Additional Sterilization Chamber For The CardioMEMS PA Sensor And Delivery System (CM2000) At The Abbott Sylmar, CA Facility |
| 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 |