- Device
- Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S125
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2025-06-23
- Decision code
- APPR
- Date received
- 2025-03-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for a change to the Automated Impella Controller (AIC) battery pack cells and gas gauge integrated circuit