- Device
- Impella 2.5, Impella CP, Impella CP with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S098
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2022-07-08
- Decision code
- APPR
- Date received
- 2022-04-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the updated labeling with the information from the Impella PROTECTED PCI Post-Approval cVAD Registry Study.