Product code PYX
- Device name
- Temporary Non-Roller Type Right Heart Support Blood Pump
- Medical specialty
- Cardiovascular
- Device class
- 3
- Regulation number
- 870.4360
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Providing temporary partial or full right heart circulatory support.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P170011S063 | Impella RP System | Abiomed, Inc. | 2026-04-01 |
| P170011S061 | Impella RP System, Impella RP with Smart Assist System, Impella RP Flex System | Abiomed, Inc. | 2026-02-06 |
| P170011S062 | Impella CP with SmartAssist; Impella 5.5 with SmartAssist | Abiomed, Inc. | 2025-12-19 |
| P170011S060 | Impella RP, Impella RP with SmartAssist, Impella RP Flex with SmartAssist | Abiomed, Inc. | 2025-09-19 |
| P170011S058 | Purge Cassette | Abiomed, Inc. | 2025-09-15 |
| P170011S056 | Impella RP System; Impella RP with SmartAssist System; Impella RP Flex with SmartAssist System; | Abiomed, Inc. | 2025-08-01 |
| P170011S059 | Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist | Abiomed, Inc. | 2025-07-25 |
| P170011S057 | Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist | Abiomed, Inc. | 2025-06-23 |
| P170011S055 | Impella RP with SmartAssist, Impella RP Flex with SmartAssist | Abiomed, Inc. | 2025-01-10 |
| P170011S053 | Impella RP and Impella RP with SmartAssist | Abiomed, Inc. | 2024-04-17 |
| P170011S052 | Impella RP, Impella RP with SmartAssist and Impella RP Flex Systems | Abiomed, Inc. | 2023-12-21 |
| P170011S050 | Impella RP Flex with SmartAssist | Abiomed, Inc. | 2023-06-23 |
| P170011S049 | Impella RP, Impella RP with Smart Assist, Impella $.0/LD | Abiomed, Inc. | 2023-04-27 |
| P170011S048 | Impella RP Flex with SmartAssist | Abiomed, Inc. | 2023-03-31 |
| P170011S047 | Impella RP, Impella RP with SmartAssist | Abiomed, Inc. | 2022-12-05 |
| P170011S040 | Impella RP Flex with SmartAssist and Impella RP with SmartAssist | Abiomed, Inc. | 2022-10-28 |
| P170011S039 | Impella RP Flex with SmartAssist | Abiomed, Inc. | 2022-10-28 |
| P170011S046 | Impella RP and Impella RP with SmartAssist | Abiomed, Inc. | 2022-10-11 |
| P170011S044 | Impella RP, Impella RP with SmartAssist | Abiomed, Inc. | 2022-10-06 |
| P170011S045 | Impella RP, Impella RP with SmartAssist | Abiomed, Inc. | 2022-08-31 |
| P170011S043 | Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist | Abiomed, Inc. | 2022-08-19 |
| P170011S042 | Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist | Abiomed, Inc. | 2022-07-01 |
| P170011S041 | Impella RP, Impella RP with Smart Assist | Abiomed, Inc. | 2022-06-16 |
| P170011S035 | Impella RP System, Impella RP with SmartAssist System | Abiomed, Inc. | 2022-04-19 |
| P170011S038 | Impella RP, Impella RP with SmartAssist | Abiomed, Inc. | 2022-04-12 |
| P170011S036 | Impella RP and Impella RP with SmartAssist | Abiomed, Inc. | 2022-03-16 |
| P170011S037 | Impella RP, Impella RP with SmartAssist | Abiomed, Inc. | 2022-03-08 |
| P170011S034 | Impella RP | Abiomed, Inc. | 2021-11-22 |
| P170011S033 | Impella RP System | Abiomed, Inc. | 2021-07-12 |
| P170011S031 | Impella RP System | Abiomed, Inc. | 2021-07-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00813502010985 | Impella | Abiomed, Inc. | 2023-08-08 |
| 00813502011401 | Impella | Abiomed, Inc. | 2023-07-31 |
| 00813502012477 | Impella | Abiomed, Inc. | 2023-06-19 |
| 04260113630259 | Impella | Abiomed, Inc. | 2023-06-19 |
| 00813502011869 | Impella | Abiomed, Inc. | 2023-06-19 |
| 00813502012811 | Impella | Abiomed, Inc. | 2023-02-15 |
| 00813502010022 | Impella | Abiomed, Inc. | 2016-10-21 |
| 00813502011029 | Impella | Abiomed, Inc. | 2016-01-20 |
| 00813502011135 | Impella | Abiomed, Inc. | 2014-07-31 |