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 RP, Impella RP with SmartAssist |
| Generic Name | Temporary Non-roller Type Right Heart Support Blood Pump |
| Applicant | Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS047 Date Received11/03/2022 Decision Date12/05/2022 Product Code PYX Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-11-03 |
| Decision Date | 2022-12-05 |
| PMA | P170011 |
| Supplement | S047 |
| Product Code | PYX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abiomed, Inc. 22 Cherry Hill Drive danvers, MA 01923 PMA NumberP170011 Supplement NumberS047 Date Received11/03/2022 Decision Date12/05/2022 Product Code PYX Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Various Modifications To The Instructions For Use To Add The Final Results Of Post-Approval Study (PAS) #1, Impella RP Real-World Evidence Evaluation And Periodic Reporting, Ordered In Our September 20, 2017, Letter And To Update The Indications For Use Statement Based On The PAS Results. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00813502011029 | P170011 | 000 |
| 00813502011869 | P170011 | 030 |
| 00813502012811 | P170011 | 039 |