ABIOMED EUROPE GMBH

FDA Device Registration & Listing · Aachen North Rhine-Westphalia, DE · Registration 3007904765

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007904765
FEI Number
3007904765
Entity Name
ABIOMED EUROPE GMBH
City/State/Country
Aachen North Rhine-Westphalia, DE
Establishment Address
Neuenhofer Weg 3, Aachen North Rhine-Westphalia 52074, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Abiomed Europe GmbH (Owner Number: 10030761)
Owner / Operator Contact Address
Neuenhofer Weg 3, Aachen, DE-NW 52074, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P140003

All Registered Proprietary Names

Impella RP Impella RP Flex with SmartAssist Impella RP with SmartAssist Impella CP Impella 5 Impella LD Impella 2.5

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PYX Temporary Non-Roller Type Right Heart Support Blood Pump Cardiovascular Class 3 870.4360 2017-11-09
OZD Temporary Non-Roller Type Left Heart Support Blood Pump Unknown Class 3 N/A 2018-02-27

Official Correspondent

No official correspondent registered.

US Agent Details

Anshul Shah Business: Abiomed, Inc. Email: ashah128@its.jnj.com Phone: (323) 5415318

Related Public Records

Same Entity

Abiomed Europe GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007904765. Last updated year: 2026. Please use registration number 3007904765 when referencing this establishment in official correspondence.
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