Impella RP and Impella RP with SmartAssist
FDA PMAEUDAMEDClass III (US FDA PMA)
Identity
- Trade Name
- Impella RP EUDAMEDImpella RP System FDA PMA
- Generic Name
- Temporary non-roller type right heart support blood pump FDA PMA
- Device Name
- Impella RP EUDAMED
- Model / Reference
- 0046-3107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813502012033 EUDAMED
- Basic UDI-DI
- B-00813502012033 EUDAMED
- PMA Number
- P170011 FDA PMA
- FDA Product Code
- PYX FDA PMA
- EMDN Code
- C99 CARDIOCIRCULATORY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMEDFDA PMA
- Legislation / Framework
- 21 CFR Part 870.4360 FDA PMA
- Regulation Number
- 870.4360 FDA PMA
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Impella RP and Impella RP with SmartAssist are temporary non-roller type right heart support blood pumps designed to provide circulatory assistance. These devices are indicated for patients with a body surface area of 1.5 m2 or greater who experience acute right heart failure or decompensation.
Clinical application is intended for temporary right ventricular support for a duration of up to 14 days. This support may be utilized following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. The system is authorized under FDA PMA P170011.
Frequently asked questions
What is the primary function of the Impella RP system?
The Impella RP is a temporary non-roller type blood pump designed to provide right ventricular support for patients experiencing acute right heart failure or decompensation.
Who is a candidate for the Impella RP device?
The device is indicated for patients with a body surface area of 1.5 m2 or greater who develop right heart failure following specific cardiac events, including myocardial infarction, heart transplant, open-heart surgery, or left ventricular assist device implantation.
How long can the Impella RP system be used?
The Impella RP system is indicated for temporary support, providing right ventricular assistance for a duration of up to 14 days.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Impella – Wikipedia, Impella CP® mit SmartAssist - HeartRecovery, Impella - Wikipedia
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Active |
| FDA PMA | United States | FDA_PMA | P170011 | Class III | Active |
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Manufacturer
- Manufacturer
- Abiomed, Inc.
Sources (2)
- FDA PMA P170011 24 fields · synced Sep 18, 2026
- EUDAMED 6c601797-4528-4139-9a39-7dc40af92728 61 fields · synced Jul 27, 2026