Class IIIMDR 2017/745On the marketActive deviceImplantable
- Manufacturer
- HeartWare, Inc.
- Manufacturer SRN
- US-MF-000019976
- UDI-DI
- 00763000923747
- Basic UDI-DI
- 0763000B000092489
- Reference
- MCS1621PC
- EMDN
- J01030102
- EMDN description
- IMPLANTABLE LEFT MONOVENTRICULAR ASSISTANCE SYSTEMS (LVAD)
- First on market country
- -
- Safety summary (SSCP/SSP)
- SSCP004 · Rev. 11
- Authorised representative
- Medtronic B.V.
- Last updated
- 24.09.2026 02:53