Addition of an alternative biological indicator (bi) for the sterilization of all impella family of catheters and the adoption of impella cp with smartassist into the existing sterilization cycle for other impella catheters at an alternate site.
| Device | Impella CP with SmartAssist; Impella 2.5/5.0 LD; Impella CP; Impella LD |
| 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 | 2018-07-31 |
| Decision Date | 2018-08-22 |
| PMA | P140003 |
| Supplement | S037 |
| 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 |
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