Modification to the acceptance criterion for a quality inspection related to the purge flow performance.
| Device | Impella RP System |
| 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 | 2018-01-09 |
| Decision Date | 2018-01-16 |
| PMA | P170011 |
| Supplement | S004 |
| 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