- Device
- Impella2.5, ImpellaCP, Impella CP with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S106
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2023-01-06
- Decision code
- APPR
- Date received
- 2022-10-14
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for various labeling updates regarding arterial access and timing of Impella use in the setting of acute myocardial infarction complicated by cardiogenic shock.