The addition of an in-house pairing process for 4g patient electronic systems
Device | CardioMEMS HF System |
Generic Name | System, Hemodynamic, Implantable |
Applicant | St. Jude Medical |
Date Received | 2021-06-04 |
Decision Date | 2021-07-01 |
PMA | P100045 |
Supplement | S055 |
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