Impella CP with SmartAssist System, Impella 5.5 with SmartAssist System
FDA premarket approval P140003/S089 · decided 2021-11-22
Approval details
- PMA number
- P140003
- Supplement
- S089
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Impella CP with SmartAssist System, Impella 5.5 with SmartAssist System
- Generic name
- Temporary non-roller type left heart support blood pump
- Applicant
- Abiomed, Inc.
- Date received
- 2021-09-15
- Decision date
- 2021-11-22
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- OZD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- Approval for the design change to two strain relief subcomponents of the pump handle.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |