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 RP |
| Classification Name | Temporary Non-roller Type Right Heart Support Blood Pump |
| Generic Name | Temporary Non-roller Type Right Heart Support Blood Pump |
| Applicant | Abiomed, Inc. |
| Date Received | 2018-07-31 |
| Decision Date | 2018-08-22 |
| PMA | P170011 |
| Supplement | S007 |
| Product Code | PYX |
| 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 Drive danvers, MA 01923 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P170011 | | Original Filing |
| S047 |
2022-11-03 |
Normal 180 Day Track No User Fee |
| S046 |
2022-09-15 |
30-day Notice |
| S045 |
2022-08-05 |
30-day Notice |
| S044 | | |
| S043 | | |
| S042 |
2022-06-03 |
30-day Notice |
| S041 |
2022-05-24 |
30-day Notice |
| S040 | | |
| S039 | | |
| S038 |
2022-03-24 |
30-day Notice |
| S037 |
2022-02-09 |
30-day Notice |
| S036 |
2021-12-17 |
Real-time Process |
| S035 | | |
| S034 |
2021-07-08 |
Normal 180 Day Track |
| S033 |
2021-05-03 |
Normal 180 Day Track No User Fee |
| S032 |
2021-03-31 |
Normal 180 Day Track |
| S031 |
2020-12-31 |
Normal 180 Day Track |
| S030 |
2020-12-30 |
Normal 180 Day Track |
| S029 |
2020-12-15 |
Normal 180 Day Track No User Fee |
| S028 |
2020-10-16 |
30-day Notice |
| S027 | | |
| S026 | | |
| S025 |
2020-06-15 |
Normal 180 Day Track No User Fee |
| S024 |
2020-04-10 |
Real-time Process |
| S023 |
2020-03-23 |
30-day Notice |
| S022 |
2020-03-09 |
30-day Notice |
| S021 |
2020-01-28 |
Real-time Process |
| S020 |
2019-12-26 |
30-day Notice |
| S019 |
2019-10-30 |
30-day Notice |
| S018 |
2019-10-25 |
30-day Notice |
| S017 |
2019-09-30 |
30-day Notice |
| S016 |
2019-09-03 |
30-day Notice |
| S015 | | |
| S014 |
2019-08-26 |
Special (immediate Track) |
| S013 |
2019-05-31 |
30-day Notice |
| S012 |
2019-05-31 |
30-day Notice |
| S011 |
2019-03-15 |
Normal 180 Day Track No User Fee |
| S010 |
2019-03-15 |
Special (immediate Track) |
| S009 | | |
| S008 |
2018-09-06 |
Real-time Process |
| S007 |
2018-07-31 |
30-day Notice |
| S006 |
2018-07-25 |
30-day Notice |
| S005 |
2018-02-27 |
Real-time Process |
| S004 |
2018-01-09 |
30-day Notice |
| S003 |
2017-12-18 |
Normal 180 Day Track No User Fee |
| S002 |
2017-12-18 |
Normal 180 Day Track No User Fee |
| S001 |
2017-12-05 |
Real-time Process |
NIH GUDID Devices