- Device
- Impella 5.5 with SmartAssist System; Impella CP with SmartAssist System; Impella 2.5; Impella 5.0; Impella LD;
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S123
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2025-08-01
- Decision code
- APPR
- Date received
- 2025-02-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- approval for modifying the Impella labeling to reflect the findings of the Impella Sodium Bicarbonate Post-Approval Study