Impella CP with SmartAssist; Impella 5.5 with SmartAssist
FDA premarket approval P170011/S062 · decided 2025-12-19
Approval details
- PMA number
- P170011
- Supplement
- S062
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Impella CP with SmartAssist; Impella 5.5 with SmartAssist
- Generic name
- Temporary non-roller type right heart support blood pump
- Applicant
- Abiomed, Inc.
- Date received
- 2025-11-19
- Decision date
- 2025-12-19
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- PYX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- to change the clean room classification used for manufacturing at the Danvers, Massachusetts facility
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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 |