Impella RP with SmartAssist, Impella RP Flex with SmartAssist
FDA premarket approval P170011/S055 · decided 2025-01-10
Approval details
- PMA number
- P170011
- Supplement
- S055
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Impella RP with SmartAssist, Impella RP Flex with SmartAssist
- Generic name
- Temporary non-roller type right heart support blood pump
- Applicant
- Abiomed, Inc.
- Date received
- 2024-12-19
- Decision date
- 2025-01-10
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- PYX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- approval for a labeling change to reinforce the risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and the inlet of the Impella pumps during the insertion, manipulation, and removal of those devices.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 14Fr Low Profile Introducer Kit (K252766) | Abiomed, Inc. | 2025-10-08 |
| Abiomed 14Fr Low Profile Introducer Kit (K241708) | Abiomed, Inc. | 2024-08-06 |
| preCARDIA Occlusion System (K221294) | Abiomed, Inc. | 2023-06-30 |
| OXY-1 System (K223161) | Abiomed, Inc. | 2023-02-23 |
| Abiomed 14Fr Low Profile Introducer Set (K222113) | Abiomed, Inc. | 2022-10-13 |
| Impella XR Sheath Set (K202330) | Abiomed, Inc. | 2020-12-07 |
| OXY-1 System (K200109) | Abiomed, Inc. | 2020-10-23 |
| Abiomed 23 Fr Sheath (K201116) | Abiomed, Inc. | 2020-06-15 |