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 | Impella2.5, ImpellaCP, Impella CP with SmartAssist |
| Generic Name | Temporary Non-roller Type Left Heart Support Blood Pump |
| Applicant | ABIOMED, INC.22 Cherry Hill Dr.danvers, MA 01923 PMA NumberP140003 Supplement NumberS106 Date Received10/14/2022 Decision Date01/06/2023 Product Code OZD Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-10-14 |
| Decision Date | 2023-01-06 |
| PMA | P140003 |
| Supplement | S106 |
| Product Code | OZD |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| 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 PMA NumberP140003 Supplement NumberS106 Date Received10/14/2022 Decision Date01/06/2023 Product Code OZD Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Various Labeling Updates Regarding Arterial Access And Timing Of Impella Use In The Setting Of Acute Myocardial Infarction Complicated By Cardiogenic Shock. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00813502011388 | P140003 | 000 |
| 00813502011401 | P140003 | 000 |
| 00813502011876 | P140003 | 000 |
| 00813502012279 | P140003 | 000 |
| 00813502010510 | P140003 | 000 |
| 00813502013030 | P140003 | 000 |
| 04260113630259 | P140003 | 000 |
| 00813502010022 | P140003 | 000 |
| 00813502011135 | P140003 | 000 |
| 00813502011258 | P140003 | 000 |
| 04260113630174 | P140003 | 004 |
| 00813502011371 | P140003 | 026 |
| 00813502011531 | P140003 | 050 |
| 00813502012460 | P140003 | 078 |
| 00813502012828 | P140003 | 094 |
| 00813502011371 | P140003 | 106 |