Impella RP Flex with SmartAssist
FDA premarket approval P170011/S050 · decided 2023-06-23
Approval details
- PMA number
- P170011
- Supplement
- S050
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Impella RP Flex with SmartAssist
- Generic name
- Temporary non-roller type right heart support blood pump
- Applicant
- Abiomed, Inc.
- Date received
- 2023-05-26
- Decision date
- 2023-06-23
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- PYX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- Approval for updates to the Instructions for Use (IFU) to include warning statements and clinical recommendations related to risk of thrombus formation or deposition in the Impella RP Flex with SmartAssist when indwelling venous lines or cannulas are present.
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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 |