Approval for the addition of information on heparin anticoagulation management to the impella systems instructions for use (ifus).
| Device | Impella 2.5, Impella CP, Impella CP with SmatAssist, Impella 5.0/LD Systems |
| Classification Name | Temporary Non-roller Type Left Heart Support Blood Pump |
| Generic Name | Temporary Non-roller Type Left Heart Support Blood Pump |
| Applicant | ABIOMED, INC. |
| Date Received | 2019-08-26 |
| Decision Date | 2019-09-24 |
| PMA | P140003 |
| Supplement | S056 |
| Product Code | OZD |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABIOMED, INC. 22 Cherry Hill Dr. danvers, MA 01923 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P140003 | | Original Filing |
| S106 |
2022-10-14 |
Real-time Process |
| S105 |
2022-08-16 |
30-day Notice |
| S104 | | |
| S103 |
2022-08-05 |
30-day Notice |
| S102 |
2022-07-20 |
Normal 180 Day Track No User Fee |
| S101 |
2022-06-03 |
30-day Notice |
| S100 |
2022-05-24 |
30-day Notice |
| S099 | | |
| S098 | | |
| S097 |
2022-03-24 |
30-day Notice |
| S096 | | |
| S095 |
2022-02-09 |
30-day Notice |
| S094 | | |
| S093 | | |
| S092 | | |
| S091 | | |
| S090 | | |
| S089 |
2021-09-15 |
Real-time Process |
| S088 | | |
| S087 |
2021-07-26 |
30-day Notice |
| S086 | | |
| S085 | | |
| S084 | | |
| S083 |
2021-05-03 |
Normal 180 Day Track No User Fee |
| S082 |
2021-05-03 |
Normal 180 Day Track No User Fee |
| S081 |
2021-05-03 |
Normal 180 Day Track No User Fee |
| S080 |
2021-03-31 |
Normal 180 Day Track |
| S079 |
2021-01-19 |
30-day Notice |
| S078 | | |
| S077 |
2020-10-16 |
30-day Notice |
| S076 | | |
| S075 |
2020-08-10 |
30-day Notice |
| S074 | | |
| S073 |
2020-04-10 |
Real-time Process |
| S072 | | |
| S071 |
2020-03-23 |
30-day Notice |
| S070 |
2020-02-13 |
Real-time Process |
| S069 |
2020-02-10 |
30-day Notice |
| S068 | | |
| S067 | | |
| S066 |
2019-12-23 |
Special (immediate Track) |
| S065 | | |
| S064 |
2019-11-20 |
30-day Notice |
| S063 |
2019-10-30 |
30-day Notice |
| S062 |
2019-10-25 |
30-day Notice |
| S061 |
2019-09-30 |
30-day Notice |
| S060 | | |
| S059 | | |
| S058 |
2019-09-03 |
30-day Notice |
| S057 | | |
| S056 |
2019-08-26 |
Special (immediate Track) |
| S055 |
2019-06-03 |
30-day Notice |
| S054 |
2019-05-31 |
30-day Notice |
| S053 |
2019-05-31 |
30-day Notice |
| S052 |
2019-05-28 |
30-day Notice |
| S051 |
2019-04-08 |
30-day Notice |
| S050 | | |
| S049 |
2019-02-27 |
Real-time Process |
| S048 |
2019-02-21 |
30-day Notice |
| S047 | | |
| S046 |
2019-01-29 |
30-day Notice |
| S045 |
2019-01-03 |
30-day Notice |
| S044 | | |
| S043 |
2018-11-21 |
30-day Notice |
| S042 |
2018-11-20 |
30-day Notice |
| S041 | | |
| S040 |
2018-09-06 |
Real-time Process |
| S039 |
2018-08-10 |
30-day Notice |
| S038 |
2018-07-31 |
30-day Notice |
| S037 |
2018-07-31 |
30-day Notice |
| S036 |
2018-05-15 |
30-day Notice |
| S035 |
2018-05-14 |
30-day Notice |
| S034 |
2018-05-10 |
30-day Notice |
| S033 |
2018-05-07 |
Real-time Process |
| S032 |
2018-04-20 |
30-day Notice |
| S031 |
2018-04-05 |
30-day Notice |
| S030 |
2018-03-30 |
Normal 180 Day Track No User Fee |
| S029 |
2018-02-27 |
Real-time Process |
| S028 |
2018-02-13 |
Normal 180 Day Track |
| S027 |
2017-09-29 |
Normal 180 Day Track |
| S026 |
2017-09-05 |
Normal 180 Day Track |
| S025 |
2017-08-29 |
Real-time Process |
| S024 |
2017-07-26 |
30-day Notice |
| S023 |
2017-07-25 |
Real-time Process |
| S022 |
2017-06-30 |
30-day Notice |
| S021 |
2017-06-16 |
Special (immediate Track) |
| S020 |
2017-06-06 |
135 Review Track For 30-day Notice |
| S019 |
2017-05-23 |
30-day Notice |
| S018 |
2017-04-03 |
Panel Track |
| S017 |
2017-03-30 |
Normal 180 Day Track No User Fee |
| S016 |
2017-02-21 |
135 Review Track For 30-day Notice |
| S015 |
2016-12-29 |
30-day Notice |
| S014 |
2016-11-28 |
Real-time Process |
| S013 |
2016-11-14 |
Real-time Process |
| S012 |
2016-06-29 |
135 Review Track For 30-day Notice |
| S011 |
2016-06-17 |
135 Review Track For 30-day Notice |
| S010 |
2016-06-10 |
Normal 180 Day Track No User Fee |
| S009 |
2016-06-10 |
Normal 180 Day Track No User Fee |
| S008 |
2016-06-07 |
Normal 180 Day Track |
| S007 |
2016-01-19 |
30-day Notice |
| S006 |
2015-09-15 |
Real-time Process |
| S005 |
2015-08-13 |
Panel Track |
| S004 |
2015-08-12 |
Panel Track |
| S003 |
2015-06-24 |
30-day Notice |
| S002 |
2015-06-05 |
Special (immediate Track) |
| S001 |
2015-05-22 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices