Data / Medical devices / Germany / Abiomed Europe GMBH
Abiomed Europe GMBH: FDA-registered device maker in Aachen North Rhine-Westphalia, Germany, 2 PMA approvals
Abiomed Europe GMBH is registered with the FDA (registration 3007904765) in Aachen North Rhine-Westphalia, Germany. It lists 2 device types. The FDA files 2 PMA approvals under its listings, the newest dated September 20, 2017. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007904765
- Address
- Neuenhofer Weg 3, Aachen North Rhine-Westphalia, Germany, 52074
- Owner or operator
- Abiomed Europe GmbH (10030761)
- Roles
- Manufacturer
- First device listed
- November 9, 2017
- Registered through
- 2026
- Brand names listed
- Impella 2.5, Impella 5, Impella CP, Impella LD, Impella RP, Impella RP Flex with SmartAssist, Impella RP with SmartAssist
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Temporary Non-Roller Type Left Heart Support Blood Pump | OZD | 3 | Manufacturer | accessdata.fda.gov |
| Temporary Non-Roller Type Right Heart Support Blood Pump | PYX | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 20, 2017 | P170011 | Impella RP System | PYX | 61 | April 1, 2026 | accessdata.fda.gov |
| March 23, 2015 | P140003 | IMPELLA 2.5 System | OZD | 127 | June 15, 2026 | accessdata.fda.gov |
Updated April 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.