IMPELLA 2.5 System
FDA premarket approval P140003 · decided 2015-03-23
Approval details
- PMA number
- P140003
- Trade name
- IMPELLA 2.5 System
- Generic name
- Temporary non-roller type left heart support blood pump
- Applicant
- Abiomed, Inc.
- Date received
- 2014-03-18
- Decision date
- 2015-03-23
- Days to decision
- 370 days
- Decision code
- APPR
- Product code
- OZD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR THE IMPELLA. THIS DEVICE IS INDICATED FOR:THE IMPELLA 2.5 SYSTEM IS A TEMPORARY (<= 6 HOURS) VENTRICULAR SUPPORT DEVICE INDICATED FOR USE DURING HIGH RISK PERCUTANEOUS CORONARY INTERVENTIONS (PCI) PERFORMED IN ELECTIVE OR URGENT, HEMODYNAMICALLY STABLE PATIENTS WITH SEVERE CORONARY ARTERY DISEASE AND DEPRESSED LEFT VENTRICULAR EJECTION FRACTION, WHEN A HEART TEAM, INCLUDING A CARDIAC SURGEON, HAS DETERMINED HIGH RISK PCI IS THE APPROPRIATE THERAPEUTIC OPTION. USE OF THE IMPELLA 2.5
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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 |