- Device
- Impella 5.5 with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S086
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2021-10-15
- Decision code
- APPR
- Date received
- 2021-07-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a revision of the Automated Impella Controller software related to the detection of obstructions of purge flow in the Impella 5.5 with Smart Assist.