Approval for the impella 2. 5, impella cp, impella 5. 0, and impella ld catheters, in conjunction with the automated impella controller, are temporary ventricular support devices intended for short term use (
| Device | IMPELLA VENTRICULAR SUPPORT 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 | 2015-08-12 |
| Decision Date | 2016-04-07 |
| Notice Date | 2016-07-05 |
| PMA | P140003 |
| Supplement | S004 |
| Product Code | OZD |
| Docket Number | 16M-1915 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel 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 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
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