Impella2.5, ImpellaCP, Impella CP with SmartAssist

FDA PMAEUDAMED

Class III (US FDA PMA)

PMA P140003

by Abiomed, Inc.

Identity

Trade Name: IMPELLA 2.5 System FDA PMA
Generic Name: Temporary non-roller type left heart support blood pump FDA PMA

Identifiers

PMA Number: P140003 FDA PMA
FDA Product Code: OZD FDA PMA

Classification

Device Class: Class III FDA PMA
Advisory Committee: Cardiovascular FDA PMA
FDA Decision: APPR Approved FDA PMA

The Impella 2.5 and Impella CP are temporary non-roller type left heart support blood pumps designed to provide ventricular support. These systems are indicated for use during high-risk percutaneous coronary interventions in hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction.

These devices are intended for use when a heart team has determined that high-risk percutaneous coronary intervention is the appropriate therapeutic option. The systems are designed to prevent hemodynamic instability during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events. The Impella 2.5 system is indicated for temporary use for up to 6 hours.

Frequently asked questions

What is the primary function of the Impella 2.5 and Impella CP systems?

These devices function as temporary non-roller type left heart support blood pumps that provide ventricular support to patients undergoing high-risk percutaneous coronary interventions.

Which patients are candidates for the Impella 2.5 system?

The system is indicated for hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction who are undergoing high-risk percutaneous coronary interventions as determined by a heart team.

How long can the Impella 2.5 system be used?

The Impella 2.5 system is indicated for temporary ventricular support for a duration of up to 6 hours.

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: Explore Impella CP® with SmartAssist® Heart Pump, ABIOMED, INC. FDA Filings - FDA.report, Impella2.5, ImpellaCP, Impella CP with SmartAssist PMA P140003 ..., Abiomed, Inc. - 190 FDA 510(k) clearances - Atlas by Auro

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

MDD

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class III	Active
EUDAMED	European Union	MDD	—	Class III	Active
FDA PMA	United States	FDA_PMA	P140003	Class III	Active

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Manufacturer

Manufacturer: Abiomed, Inc.

Sources (2)

FDA PMA P140003 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 18, 2026