Impella CP with SmartAssist; Impella 2.5/5.0 LD; Impella CP; Impella LD
FDA premarket approval P140003/S037 · decided 2018-08-22
Approval details
- PMA number
- P140003
- Supplement
- S037
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Impella CP with SmartAssist; Impella 2.5/5.0 LD; Impella CP; Impella LD
- Generic name
- Temporary non-roller type left heart support blood pump
- Applicant
- Abiomed, Inc.
- Date received
- 2018-07-31
- Decision date
- 2018-08-22
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- OZD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- Addition of an alternative biological indicator (BI) for the sterilization of all Impella family of catheters and the adoption of Impella CP with SmartAssist into the existing sterilization cycle for other Impella catheters at an alternate site.
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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 |