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 | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with Smart Assist |
| Generic Name | Temporary Non-roller Type Left Heart Support Blood Pump |
| Applicant | ABIOMED, INC.22 Cherry Hill Dr.danvers, MA 01923 PMA NumberP140003 Supplement NumberS100 Date Received05/24/2022 Decision Date06/16/2022 Product Code OZD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-05-24 |
| Decision Date | 2022-06-16 |
| PMA | P140003 |
| Supplement | S100 |
| Product Code | OZD |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABIOMED, INC. 22 Cherry Hill Dr. danvers, MA 01923 PMA NumberP140003 Supplement NumberS100 Date Received05/24/2022 Decision Date06/16/2022 Product Code OZD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement implementation Of A Centralized Inert Gas Distribution System At A Manufacturing Facility |
| 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 |