Class IIIMDR 2017/745Not intended for EU marketActive deviceImplantableSingle useSterile
- Manufacturer
- Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation
- Manufacturer SRN
- US-MF-000010993
- UDI-DI
- 00802526594038
- Basic UDI-DI
- 01915060000000000000084MY
- Reference
- D413
- EMDN
- J01050101
- EMDN description
- IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS
- First on market country
- -
- Safety summary (SSCP/SSP)
- 92721803 · Rev. D
- Authorised representative
- Guidant Europe NV/SA; Boston Scientific
- Last updated
- 12.08.2026 15:18