FDA.reportPublic FDA data

ABIOMED EUROPE GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30079047653007904765ABIOMED EUROPE GMBH1N2026-01-01Neuenhofer Weg 3 Aachen North Rhine-Westphalia DE 52074

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1100301718042238P170011Impella RP SystemPYX2017-09-20
1100301232118858P140003IMPELLA 2.5 SystemOZD2015-03-23
1100301934031716K112892IMPELLA 2.5 PLUS CATHETERPBL2012-09-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PYX12017-09-20
OZD12015-03-23
PBL12012-09-06