- Device
- Impella CP with SmartAssist, Impella 5.5 with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S118
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2024-09-12
- Decision code
- APPR
- Date received
- 2024-08-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for changes to the device labeling for the continued safe use of Impella catheters when used with the Shockwave Coronary Intravascular Lithotripsy (IVL) catheter