| Impella CP with SmartAssist; Impella 5.5 with SmartAssist (P140003/S136) | Abiomed, Inc. | 2025-12-19 |
| Impella CP with SmartAssist; Impella 5.5 with SmartAssist (P170011/S062) | Abiomed, Inc. | 2025-12-19 |
| Impella 5.5 with SmartAssist (P140003/S131) | Abiomed, Inc. | 2025-10-01 |
| Impella CP with SmartAssist (P140003/S130) | Abiomed, Inc. | 2025-09-24 |
| Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist; Impella LD (P140003/S129) | Abiomed, Inc. | 2025-09-19 |
| Impella RP, Impella RP with SmartAssist, Impella RP Flex with SmartAssist (P170011/S060) | Abiomed, Inc. | 2025-09-19 |
| Purge Cassette (P170011/S058) | Abiomed, Inc. | 2025-09-15 |
| Impella 5.5 with SmartAssist, Impella CP with SmartAssist, Purge Cassette (P140003/S126) | Abiomed, Inc. | 2025-09-15 |
| Impella CP with SmartAssist System (P140003/S124) | Abiomed, Inc. | 2025-08-08 |
| Impella 5.5 with SmartAssist System; Impella CP with SmartAssist System; Impella 2.5; Impella 5.0; Impella LD; (P140003/S123) | Abiomed, Inc. | 2025-08-01 |
| Impella RP System; Impella RP with SmartAssist System; Impella RP Flex with SmartAssist System; (P170011/S056) | Abiomed, Inc. | 2025-08-01 |
| Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist (P170011/S059) | Abiomed, Inc. | 2025-07-25 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD (P140003/S128) | Abiomed, Inc. | 2025-07-25 |
| Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist (P170011/S057) | Abiomed, Inc. | 2025-06-23 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD (P140003/S125) | Abiomed, Inc. | 2025-06-23 |
| IMPELLA CP with Smart Assist (P140003/S127) | Abiomed, Inc. | 2025-06-20 |
| Impella CP with SmartAssist (P140003/S122) | Abiomed, Inc. | 2025-02-04 |
| Impella RP with SmartAssist, Impella RP Flex with SmartAssist (P170011/S055) | Abiomed, Inc. | 2025-01-10 |
| Impella CP with SmartAssist, Impella 5.5 with SmartAssist (P140003/S111) | Abiomed, Inc. | 2024-12-03 |
| Impella CP with SmartAssist (P140003/S121) | Abiomed, Inc. | 2024-10-29 |
| Impella 5.5 with SmartAssist (P140003/S119) | Abiomed, Inc. | 2024-10-21 |
| Impella CP with SmartAssist, Impella 5.5 with SmartAssist (P140003/S118) | Abiomed, Inc. | 2024-09-12 |
| Impella RP and Impella RP with SmartAssist (P170011/S053) | Abiomed, Inc. | 2024-04-17 |
| Impella CP, Impella CP with SmartAssist, Impella 2.5, Impella 5.0/LD, Impella 5.5 with SmartAssist (P140003/S116) | Abiomed, Inc. | 2024-01-05 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist Systems (P140003/S117) | Abiomed, Inc. | 2023-12-21 |
| Impella RP, Impella RP with SmartAssist and Impella RP Flex Systems (P170011/S052) | Abiomed, Inc. | 2023-12-21 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist (P140003/S115) | Abiomed, Inc. | 2023-11-29 |
| Impella CP with SmartAssist (P140003/S112) | Abiomed, Inc. | 2023-06-27 |
| Impella RP Flex with SmartAssist (P170011/S050) | Abiomed, Inc. | 2023-06-23 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist (P140003/S113) | Abiomed, Inc. | 2023-06-14 |
| Impella RP, Impella RP with Smart Assist, Impella $.0/LD (P170011/S049) | Abiomed, Inc. | 2023-04-27 |
| Impella 2.5, Impella CP and CP with SmartAssist (P140003/S110) | Abiomed, Inc. | 2023-04-27 |
| Impella CP with SmartAssist (P140003/S109) | Abiomed, Inc. | 2023-04-13 |
| Impella RP Flex with SmartAssist (P170011/S048) | Abiomed, Inc. | 2023-03-31 |
| Impella Ventricular Support Systems (P140003/S107) | Abiomed, Inc. | 2023-03-29 |
| Impella2.5, ImpellaCP, Impella CP with SmartAssist (P140003/S106) | Abiomed, Inc. | 2023-01-06 |
| Impella RP, Impella RP with SmartAssist (P170011/S047) | Abiomed, Inc. | 2022-12-05 |
| Impella CP with SmartAssist, Impella 5.5 with SmartAssist (P140003/S099) | Abiomed, Inc. | 2022-10-28 |
| Impella RP Flex with SmartAssist (P170011/S039) | Abiomed, Inc. | 2022-10-28 |
| Impella RP Flex with SmartAssist and Impella RP with SmartAssist (P170011/S040) | Abiomed, Inc. | 2022-10-28 |
| Impella RP and Impella RP with SmartAssist (P170011/S046) | Abiomed, Inc. | 2022-10-11 |
| Impella RP, Impella RP with SmartAssist (P170011/S044) | Abiomed, Inc. | 2022-10-06 |
| Impella 5.5 with SmartAssist (P140003/S094) | Abiomed, Inc. | 2022-10-04 |
| Impella CP with SmartAssist (P140003/S105) | Abiomed, Inc. | 2022-09-06 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist (P140003/S103) | Abiomed, Inc. | 2022-08-31 |
| Impella RP, Impella RP with SmartAssist (P170011/S045) | Abiomed, Inc. | 2022-08-31 |
| Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist (P170011/S043) | Abiomed, Inc. | 2022-08-19 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD (P140003/S102) | Abiomed, Inc. | 2022-08-18 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist (P140003/S098) | Abiomed, Inc. | 2022-07-08 |
| Impella 2.5, Impella CP & CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist (P140003/S096) | Abiomed, Inc. | 2022-07-08 |
| Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist (P170011/S042) | Abiomed, Inc. | 2022-07-01 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD (P140003/S101) | Abiomed, Inc. | 2022-07-01 |
| Impella RP, Impella RP with Smart Assist (P170011/S041) | Abiomed, Inc. | 2022-06-16 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with Smart Assist (P140003/S100) | Abiomed, Inc. | 2022-06-16 |
| Impella RP System, Impella RP with SmartAssist System (P170011/S035) | Abiomed, Inc. | 2022-04-19 |
| Impella 2.5 System, Impella CP System, Impella CP with SmartAssist System, Impella 5.0 System, Impella LD System,Impella (P140003/S088) | Abiomed, Inc. | 2022-04-19 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist (P140003/S097) | Abiomed, Inc. | 2022-04-12 |
| Impella RP, Impella RP with SmartAssist (P170011/S038) | Abiomed, Inc. | 2022-04-12 |
| Impella 5.5 with SmartAssist (P140003/S093) | Abiomed, Inc. | 2022-04-08 |
| Impella CP with SmartAssist (P140003/S092) | Abiomed, Inc. | 2022-04-05 |
| Impella RP and Impella RP with SmartAssist (P170011/S036) | Abiomed, Inc. | 2022-03-16 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist (P140003/S091) | Abiomed, Inc. | 2022-03-16 |
| Impella RP, Impella RP with SmartAssist (P170011/S037) | Abiomed, Inc. | 2022-03-08 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S095) | Abiomed, Inc. | 2022-03-08 |
| Impella CP with SmartAssist (P140003/S085) | Abiomed, Inc. | 2021-11-22 |
| Impella CP with SmartAssist System, Impella 5.5 with SmartAssist System (P140003/S089) | Abiomed, Inc. | 2021-11-22 |
| Impella RP (P170011/S034) | Abiomed, Inc. | 2021-11-22 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S084) | Abiomed, Inc. | 2021-11-22 |
| Impella 5.5 with SmartAssist (P140003/S086) | Abiomed, Inc. | 2021-10-15 |
| Impella 5.5 with SmartAssist (P140003/S087) | Abiomed, Inc. | 2021-08-23 |
| Impella Left Ventricular Support Systems (P140003/S082) | Abiomed, Inc. | 2021-07-13 |
| Impella Ventricular Support Systems (P140003/S083) | Abiomed, Inc. | 2021-07-13 |
| Impella Ventricular Support Systems (P140003/S081) | Abiomed, Inc. | 2021-07-13 |
| Impella RP System (P170011/S033) | Abiomed, Inc. | 2021-07-12 |
| Impella RP System (P170011/S031) | Abiomed, Inc. | 2021-07-09 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist System (P140003/S078) | Abiomed, Inc. | 2021-07-09 |
| Impella RP System (P170011/S032) | Abiomed, Inc. | 2021-06-28 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist (P140003/S080) | Abiomed, Inc. | 2021-06-28 |
| Impella RP System (P170011/S026) | Abiomed, Inc. | 2021-06-28 |
| Impella RP with SmartAssist System (P170011/S030) | Abiomed, Inc. | 2021-06-28 |
| Impella RP System (P170011/S029) | Abiomed, Inc. | 2021-06-15 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S076) | Abiomed, Inc. | 2021-03-12 |
| Impella RP (P170011/S027) | Abiomed, Inc. | 2021-03-12 |
| Impella 2.5 System, Impella CP System and Impella CP System with SmartAssist System, Impella 5.0 System, Impella LD Syst (P140003/S074) | Abiomed, Inc. | 2021-03-10 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.5 with SmartAssist, and Impella 5.0/LD (P140003/S079) | Abiomed, Inc. | 2021-02-17 |
| Impella RP (P170011/S028) | Abiomed, Inc. | 2020-11-06 |
| Impella 2.5, Impella CP, Impelia CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S077) | Abiomed, Inc. | 2020-11-06 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist. (P140003/S075) | Abiomed, Inc. | 2020-09-09 |
| Impella RP System (P170011/S025) | Abiomed, Inc. | 2020-08-04 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist (P140003/S072) | Abiomed, Inc. | 2020-08-04 |
| Impella RP System (P170011/S024) | Abiomed, Inc. | 2020-07-10 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.5 with SmartAssist, Impella 5.0, and Impella LD Systems (P140003/S073) | Abiomed, Inc. | 2020-07-10 |
| Impella 2.5, CP, and CP with SmartAssist (P140003/S065) | Abiomed, Inc. | 2020-06-26 |
| Automated Impella Controller (P140003/S070) | Abiomed, Inc. | 2020-04-17 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S071) | Abiomed, Inc. | 2020-04-09 |
| Impella RP (P170011/S023) | Abiomed, Inc. | 2020-04-09 |
| Impella RP System (P170011/S021) | Abiomed, Inc. | 2020-04-01 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD and Impella 5.5 with SmartAssist Systems (P140003/S068) | Abiomed, Inc. | 2020-04-01 |
| Impella RP System (P170011/S022) | Abiomed, Inc. | 2020-03-30 |
| Impella CP with SmartAssist (P140003/S069) | Abiomed, Inc. | 2020-02-28 |