- Device
- Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.5 with SmartAssist, Impella 5.0, and Impella LD Systems
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S073
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2020-07-10
- Decision code
- APPR
- Date received
- 2020-04-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for one-way data-streaming from the Automated Impella Controller through Impella Connect for external viewing via the internet